28 Cdsco Jobs

Are you passionate about driving clinical quality and compliance Do you have a proven track record in clinical operations and a knack for innovation and process improvement If you're ready to take on a leadership role that makes a real impact, we invite you to explore this exciting opportunity, apply today for a life-changing career! As the Head of Clinical Operational Excellence, you will play a pivotal role in ensuring clinical quality, compliance, and operational excellence. Your key responsibilities will include performing risk assessments and trend analyses to proactively address clinical quality risks, ensuring audit and inspection readiness including CAPA documentation and stakeholder communication, representing the CDC in regional and global clinical quality forums, ensuring compliance with local regulatory requirements, coordinating Quality Management Reviews (QMR), developing and executing yearly training plans aligned with operational strategies, driving innovative solutions for operational efficiency such as digital visit tracking and RBQM, identifying and implementing process improvements, conducting stakeholder satisfaction checks, measuring the effectiveness of new processes, and communicating with external Regulatory Authorities FDA, EMA, CDSCO, PMDO. To be successful in this role, you should have 15+ years of experience in clinical operations with a minimum of 3 years in clinical quality, 5 years of direct team handling experience with 360* performance management, completed qualifications in Medical, Pharmacy, Life Sciences, or another related field, a track record of driving innovation and process improvements in clinical operations, experience with digital tools and systems for operational excellence, excellent communication, and stakeholder management skills. The Clinical Development Centre (CDC) India is at the forefront of ensuring clinical quality and operational excellence. Based in a fast-paced and dynamic environment, the department proactively addresses clinical quality risks through risk assessments and trend analyses, ensures audit and inspection readiness, maintains compliance with local regulatory requirements, drives innovative solutions such as digital visit tracking and RBQM, represents CDC in global forums, and fosters collaboration with external regulatory authorities. With a culture of continuous improvement and a commitment to operational efficiency, the team thrives on delivering impactful results that make a difference. If you are interested in submitting your application, please upload your CV and motivational letter online. Internal candidates are kindly requested to inform their line Managers before applying. The deadline for applications is 01st Aug. 2025. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants. The company recognizes the importance of creating an inclusive culture that celebrates the diversity of employees, patients served, and communities operated in. Together, Novo Nordisk strives to be life changing.,

As a Regulatory Affairs Associate, you will be required to hold a Master's Degree in M. Pharm or M. Sc. with a specialization in Pharmaceutics, Industrial Pharmacy, Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, Biochemistry, or Microbiology. A minimum of 2 to 6 years of hands-on experience in R&D within Manufacturing or Import companies, specifically in MNCs and Generics, is essential for this role. Proficiency in CDSCO and Central Licensing Agency - New Delhi (SUGAM) skills, including Agency Liaison, is a priority as applications lacking these skills will not be considered. Your responsibilities will include understanding new client requirements, scope, deliverables, and timelines, reviewing and finalizing Gap Analysis Reports, effective collaboration and communication with internal and external stakeholders, technical writing of regulatory documents, liaison with licensing authorities such as CDSCO, training internal technical team members on the latest updates and guidelines, and coordinating with stakeholders. Key responsibilities will involve Regulatory Strategy, KOL/SME/Agency and Network-Access, Review of Documents/Dossiers and Gap Analysis, and Technical Writing of Regulatory Documents. This is a full-time position with a day shift from Monday to Friday, based in Bangalore (Cunningham Road), serving the Indian market for API and Finished Formulation. A willingness to travel up to 25% of the time is required, with a start date of 04/08/2025, and the application deadline is 07/07/2025.,

You will be responsible for reviewing and conducting chemical testing of raw materials, finished products, cosmetics, Ayurveda, Sidha & Unani products. You will need to accurately enter the test results into the LIMS software. Additionally, you will be required to handle instruments like HPLC, GC, FTIR, Dissolution, etc. Technical documentation in compliance with FDA, CDSCO & Ayush standards for audits will also be part of your responsibilities. The position is based in Gurugram and requires a minimum qualification of B.Pharma, M.Pharma, MSc. Chemistry or a related field. The ideal candidate should have 2 to 15 years of relevant experience.,

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Experience Required: CDSCO , USFDA, EUGMP, NAFDAC Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

KEY RESPONSIBILITIES: Delegating and directing service tasks, monitoring the progress of current projects, and managing service team members to ensure the team's objectives and sales goals are met. Handling customer complaints or concerns quickly and professionally to maintain good customer relationships and ensure repeat customers. Assisting with or performing administrative tasks, such as managing and updating invoices, processing new orders, and tracking inventory. Setting up and maintaining a service desk and evaluating its efficiency. Resolving service desk problems and improving service methods to increase the service desk's productivity and customer service. Monitoring department issues and client complaints to create methods to lessen recurring issues. Ensuring First Response Time, Complaint Handle Time, First Contact resolution are within the prescribed limits as directed by the Management. Auditing work and customer service to ensure the company's high standards, efficiency, and productivity goals are met. Ensuring Quality Standards as per ISO 9001, ISO 13485, CE MDD/MDR, USFDA, CDSCO standards and any other applicable standards and systems. Maintaining strong relationships with manufacturers, dealers, and sales representatives. Helping to train new employees in company procedures. Maintaining a strong working knowledge of industry regulations, restrictions, and laws, ensuring the company's adherence to these regulations, and remaining current on the industry's standards and new innovations, materials, tools, and processes.

Job Title: Senior Regulatory Affairs Team Lead Medical Devices Location: Chennai, India Department: Regulatory Affairs Experience Required: Minimum 5 years Reports To: Head of Regulatory Affairs / Director of Quality & Regulatory Job Summary: We are seeking a highly skilled and experienced Senior Regulatory Affairs Team Lead to manage and lead our regulatory submissions and strategy for medical devices in India. The ideal candidate will have a deep understanding of the regulatory framework governed by CDSCO (Central Drugs Standard Control Organization) and proven experience in successfully obtaining approvals for medical devices. This role requires both strategic oversight and hands-on execution, ensuring regulatory compliance and timely product registrations. Key Responsibilities: Lead Regulatory Submissions: Drive end-to-end regulatory submissions to CDSCO for new product approvals, including Class A, B, C, and D medical devices. Dossier Preparation: Oversee the compilation, review, and submission of Device Master Files (DMFs), Plant Master Files (PMFs), and other required documentation. Liaison with CDSCO: Serve as the primary point of contact with CDSCO officials, Notified Bodies, and authorized agents. Regulatory Strategy: Develop and implement regulatory strategies for both new and existing product lines, ensuring alignment with local and international regulatory standards. Team Leadership: Manage and mentor a team of regulatory associates/specialists; provide guidance on technical file preparation, regulatory pathways, and compliance. Audit Support: Participate in internal and external audits (CDSCO, ISO 13485, MDSAP), including responding to observations and ensuring closure of compliance gaps. Monitoring & Intelligence: Stay current with CDSCO regulations, guidance documents, and global regulatory trends; disseminate regulatory intelligence to internal teams. Cross-functional Collaboration: Work closely with R&D, QA, Marketing, and Supply Chain to ensure regulatory requirements are incorporated throughout the product lifecycle. Requirements: Education: Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field. Experience: Minimum 5 years of hands-on regulatory experience with medical device registrations in India, with a focus on CDSCO Class C & D devices preferred. Regulatory Knowledge: Strong understanding of the Indian Medical Device Rules (MDR), 2017 and CDSCO’s submission pathways (Form MD-14/15, MD-16/17, MD-9/10, etc.). Technical Skills: Experience preparing technical documentation (CE, 510(k), or other global dossiers is a plus). Soft Skills: Excellent communication, leadership, problem-solving, and project management skills. Certifications (preferred): RAC (Regulatory Affairs Certification), ISO 13485 knowledge, or equivalent certifications.

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team for internal / external audit compliance for ISO and CE marking Responsible for surveillance of regulatory guidance/ standards applicable to medical devices in the respective geographies in which Cipla products are distributed. Key Accountabilities: Develop, establish and maintain the QMS for medical devices according to EU MDR and ISO 13485 requirements. Surveillance of new/updated regulatory guidance/ ISO standards applicable to medical devices as per Ciplas product portfolio to ensure compliance to latest regulations. Surveillance of EU noncompliance reports / CDSCO / USFDA etc that are applicable to medical devices manufactured by Cipla to enable continuous improvement. Execution of Quality Management Review meeting for Medical devices and implementation of actions derived in the QMR meetings. Conduct audit of Vendors / contract manufacturers/ outsourced activities associated with medical device manufacturing/ servicing/ testing/ distribution. Ensure timely submission of quality documents to fulfil regulatory requirements. Major Activities / Tasks: Develop and establish Management responsibility system as per ISO 13485 and EU MDR Develop and establish design control system for EU market. Develop and establish key performance indicators (KPIs) for monitoring site performance and effectiveness of QMS as per ISO 13485. Prepare SOPs, Quality manual etc.as per ISO 13485/ EU MDR. Responsible to maintain compliance to ISO 13485 by adhering to SOPs and ensuring control and oversight over adherence by respective depts to SOPs. Periodic review of SOPs related to medical devices as per regulatory requirements and update. Arrange training and promote awareness among cross functional teams on ISO 13485 QMS and CE Marking Ensure readiness from QMS standpoint for internal and external audits. Provide guidance and support during internal and external audits examining compliance to EU MDR/ISO 13485 requirements. Co-ordinate with cross functional teams for internal/ external audit compliance. Create library of ISO standards. Review new/upcoming/ draft/ revised/ final regulatory guidance/ ISO standards related to medical devices applicable as per Ciplas product portfolio. Gap assessment of the guidance / standards in comparison to QMS at Cipla and identify suitable actions prior to implementation of the guidance/standard. Monitor implementation of the actions to enable continuous improvement. Schedule quality management review (QMR) meeting for medical devices. Collate data required for the QMR and prepare the presentation on site performance to monitor effectiveness of Quality management system. Appraise management representative regarding critical issues. Monitor implementation of the action plans derived from QMR by coordinating with other cross functional team. Audit of Vendors supplying Medical devices and Invitro diagnostic kits, completing audit documentation and verifying actions taken by the audited site to correct non-conformances observed. Audit of CMOs manufacturing medical devices, completing audit documentation, and verifying actions taken by the audited site to correct non-conformances observed. Audit of outsourced activities related to medical devices manufacturing/ servicing/ testing/ distribution. Coordinate with RA, QA team and Pharmaco vigilance team through emails and phone to enable timely submission of the documents. Major Challenges: Establishing Quality Management System for Medical devices according to EU MDR / ISO 13485 is new for Cipla, hence developing and maintaining it will be a challenge. Cross functional support is key in ensuring adherence to QMS, as challenge is awareness about EU/ ISO 13485 certification requirements is low in cross functional teams such as IPD/ RA/ SCM/FPS/ DSD, Marketing. Same can be overcome by promoting awareness about EU MDR/ISO 13485 requirements at the outset/ from time to time. Engage in Notified bodies audits for ISO and CE marking audits and coordinate with all Cipla teams for audit management. Coordinate with Cipla team for audit compliance. Skills & Knowledge: Educational qualifications: MSc./ MPharm/ if MTech then in Biomedical engineering; Certificate courses/diploma in ISO audits highly welcome Relevant experience: At least 9-10 years of experience in Quality of Medical Devices/IVDs /Implants Experience in regulated market product approvals e.g. US FDA is a high plus

Key responsibilities include: Responsible for all Regulatory related activities includes Filing, Submission, responding to DCGI queries, Customer requirements, SUGAM portal registrations, Renewal of licenses, IP commission & CDTL requirements, etc. Responsible to get approvals for the submissions to CDSCO like New drug application, FDC application, Subsequent new drug application, Import license, Test license, etc. Responsible for FSSAI annual returns filing, FosCos online license modification. Responsible for handling PV related activities, which includes PSUR submission and reporting the adverse events of pharmaceutical products for case processing, reviewing & submitting the reports to regulatory authorities. Filing & Submissions: Responsible to prepare submissions to CDSCO like New drug application, Subsequent new drug application, etc. and ensures to respond the DCGI queries & SEC recommendations in timely manner to get permissions/approvals. Responsible to collect & review all the essential documents (API vendor documents, CMC documents, Administrative part, Clinical & Non-clinical data) from CFT for submission. Managing the queries raised by CDSCO against the submitted applications and responsible for addressing the queries & requirements from Indian Pharmacopeia Commission, Central/State Testing Laboratories, SEC committee, DCGI, CDSCO. Regulatory Compliance Management Supports in customer / regulatory complaints, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Ensures that customer / regulatory complaints are adequately handled, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Evaluates, reviews and approves product claim on labels and marketing collaterals in accordance to legal and regulatory requirements. Responsible to organize and archive all regulatory documents including NOC, Product license, NSQs data, AE reports, Drug office requests by co-ordination with site Co-ordinate with the Consultants and Customers on regulatory requirements for new products and major changes in existing products. Reviews proposed changes and its supportive information for completeness and accuracy while ensuring compliance with regulations set by the Central Drugs Standard Control Organization (CDSCO) Responsible for Monitoring of Compendial/ Pharmacopeial revisions or any addition of new monographs, which impacts our system and procedure and ensuring the changes implemented in License, Artwork labelling, specification, testing methods, BMR, BPR, MMR and procedures at all sites Communicate changes in regulatory directions, regulatory intelligence and competitive activities. Notify internally via RA notification as necessary within all relevant regulatory matters Pharmacovigilance Management Responsible for submission of Periodic Safety Update Reports (PSUR) to regulatory authority as a part of new product approval/regularization within stipulated timeline. Responsible for reporting the Adverse Event PV, follow up, coordination with site QA (in case of quality complaint) and provide investigation report to customers and getting the concurrence / approval from customer on investigation and closure. Co-ordinate with CRO for processing AE cases & responsible for reviewing and submitting the reports to regulatory authorities on time. Assisting in PV projects in compliance with customer agreement and local & global regulatory guidelines. Maintain and track all CAPAs & submitted reports related to pharmacovigilance. Ensure pharmacovigilance regulatory compliance with oversight, as needed. FSSAI (Food Safety & Standards Authority of India) To perform & ensures on-time FSSAI annual returns filing (Form ‘D’) periodically. Responsible for central FSSAI license modification by including addition of products time to time and other licensing activities like Free Sale Certificate. Ensures regulatory compliance related to registration of Food Business Operator through Food Safety Compliance System (FoSCoS), Food safety audit, etc. Quality management (NSQ): Co-ordinates with site team & ensure to fulfil the drugs control requirements (Documents/ Sample) of concern FDA/DCD/DTL by responding within stipulated timeline. Collaborate & Coordinate with internal team to make a strategic plan to respond the NSQ/Showcause cases.

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled with experience in process validation and variation submissions. Your responsibilities will extend to maintaining robust electronic document management systems (EDMS) and ensuring manufacturing records align with regulatory requirements. This position demands a proactive individual with excellent communication skills to effectively liaise with regulatory agencies and internal stakeholders, ensuring Synnat Pharma maintains its commitment to quality and compliance in the pharmaceutical industry. Job Details: Industry: Pharmaceutical (API Division) Department: Regulatory Affairs Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 5,00,000 - 10,00,000 INR per annum Experience: 5-9 years Qualification: Bachelor's degree in Pharmacy, Chemistry, or related field Responsibilities: R egulatory Submissions & Documentation: Prepare, review, and submit comprehensive regulatory dossiers and technical documentation for API products to various health authorities (US FDA, EMA, CDSCO). Manage the compilation, archiving, and tracking of all regulatory documentation using electronic document management systems (EDMS). Ensure all regulatory submissions are accurate, complete, and compliant with current regulatory guidelines and requirements. Maintain up-to-date knowledge of changes in pharmaceutical regulations and guidelines and communicate these changes to relevant stakeholders. Prepare and manage Drug Master File (DMF) filings, renewals, and updates, ensuring timely submissions and compliance. Coordinate with cross-functional teams (manufacturing, quality control, R&D) to gather necessary data and documentation. Regulatory Compliance & Inspections: Lead and manage regulatory inspections conducted by health authorities, ensuring preparedness and compliance. Develop and implement corrective and preventive actions (CAPA) in response to inspection findings and regulatory queries. Conduct internal audits to ensure compliance with pharmaceutical regulations and quality standards related to API manufacturing. Review manufacturing records and analytical data to ensure compliance with regulatory requirements and guidelines. Monitor and ensure adherence to pharmacopeias (USP, EP, BP) and ICH guidelines in API manufacturing processes. Maintain a thorough understanding of API manufacturing regulatory compliance. Regulatory Communication & Liaison: Act as the primary point of contact for communication with regulatory agencies regarding submissions, queries, and inspections. Prepare and manage responses to regulatory queries and deficiency letters, ensuring timely and accurate information. Liaise with internal stakeholders to address regulatory issues and provide guidance on compliance matters. Communicate regulatory updates and changes to relevant departments. Cultivate and maintain positive relationships with regulatory agencies. Provide support and guidance to cross-functional teams on regulatory expectations. Variation & Renewal Management Prepare and submit variation applications for changes to approved API manufacturing processes and formulations. Manage the renewal process for existing regulatory approvals, ensuring timely submissions and compliance. Assess the impact of proposed changes on regulatory filings and ensure appropriate documentation is prepared. Track the status of variation and renewal applications and communicate updates to stakeholders. Ensure all variations and renewals align with current regulatory guidelines. Maintain a comprehensive record of all variations and renewals submitted General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrated experience (6-9 years) in regulatory affairs within the pharmaceutical industry, specifically in API manufacturing. Proven expertise in preparing and managing DMF filings and regulatory submissions for global health authorities (US FDA, EMA, CDSCO). Strong knowledge of pharmaceutical regulations, ICH guidelines, and pharmacopeias (USP, EP, BP). Experienced in regulatory inspections and responding to regulatory queries and deficiency letters. Proficient in EDMS and other relevant documentation systems. Excellent communication, interpersonal, and problem-solving skills with the ability to work cross-functionally.

Responsible for ensuring and carrying out tasks in accordance with FDCA, CDSCO and Prohibition Excise guidelines. Responsible for preparing the ACDF application, i.e. CoPP, renewal and new manufacturing licences. Responsible for WHO GMP, Additional Product Permission, Tender Certificate, Test License Technical person approval Responsible for preparing wholesale license, loan license, audit, and inspection reports. Responsible for preparing IT application at CDSCO i.e. Test License, Form 10, From 11, Import & Export NOC Responsible to ensure and prepare renewal of licence for prohibition and excise. Also took necessary approval for Naukarnama and do return submission and other process. You will also be responsible for any other work which may be assigned to you by the management from time to time.

Roles and Responsibilities Develop new products by leading cross-functional teams through formulation development, process development, and scale-up. Collaborate with external partners (CROs) on OSD product development and registration dossiers preparation. Ensure compliance with regulatory requirements for solid oral products at CDSCO and DCGI. Manage budgets, resources, and timelines for R&D projects to achieve business objectives. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry with expertise in AR&D. Bachelor's degree in Pharmacy (B.Pharma) followed by Master's degree (M.Pharma). Strong understanding of formulation development, formulation research, Nutraceuticals, OSDs. Proven track record of successfully leading complex projects from ideation to launch.

Roles and Responsibilities Develop and implement new product ideas through CDSCO process. Oversee research and development projects from concept to commercialization. Collaborate with cross-functional teams to ensure successful project delivery. Ensure compliance with regulatory requirements (DCgi) and maintain high standards of quality control. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry, preferably in FR&D or similar role. B.Pharma degree in Any Specialization; M.Pharma preferred but not mandatory. Strong understanding of formulation development, formulations, nutraceuticals, OSDs, and solid orals.

Job Profile for Regulatory Affairs : Participate and coordinate with various cross-functional teams by working closely with Quality assurance, Quality control for documents collections in dossier preparation. Dossier review and collection of required Pharmacology/Toxicology/Clinical data through literature&internetforpreparationofSummaryofProductCharacteristic and Patient Information Leaf lets (PIL). DMF Review Preparation and Management for submission of dossier in CTD, ACTD and Country specific format. Review of Analytical method validation verification Reports required for drug product development and submission in regulatory application. Review of stability data incompliance with specification. Review of additional stability studies protocols. Responsible for quality review of all documents related to submission. Preparation and Review of Process Validation Protocols and Reports. Preparation and Review of Cleaning Validation Protocols and Reports. Review of Master Specifications, STPs and Worksheets. MSDS, BMR’S, SMPC’s and TSE & BSE certificates Preparation Quantitative and Qualitative formula preparation Certification of analysis (FP), Preparation of Cover letter, declaration forms, Review of Artwork All Technical documents review doing well as per company Requirements SOP ODLS and DCA Portal Apply (Marketing Standard Certificate Additional Products apply Good Manufacturing Practices Certificate (GMP) Good Laboratory Practices Certificate (GLP) Free Sale Certificate on etc. ODLS. Collect documents for COPP application. Making Schedule for dossiers as per requirement of buyer to submit Regulatory Authority. Responding Quires of Dossier arises by the respective authorities. CDSCO - NOC application Documents preparation & applying online.

Head of Quality Assurance & Regulatory Affairs (QA/RA) Job Description As the In-charge of Quality Assurance and Regulatory Affairs (QA/RA), you will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality products enter emerging, regulated, and clinical global markets. You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company. Continuous improvement and ad-hoc issue resolution to drive improvement of quality operations, at the lowest costs and in full compliance of all relevant regulations and standards. Duties/Responsibilities Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. Ensure that regulated processes and systems are always inspection ready. Oversee the performance of internal and external audits. Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. Serve as person responsible for regulatory compliance (PRRC). Other duties as assigned. - To lead in new products registration and license renewal compliance to local regulations, as well as GMP, GDP and ISO requirement. - Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements. - Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements - Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. Responsible to improve and implement the QMS for ISO 9001:2008 and ISO 13485:2003, European Medical Device Directive MDD 93/42/EEC Follow-up the Indian GMP regulation and ensure compliance of the technical file according to Indian regulation. Responsible for monitoring of critical processes for site in compliance of operations, Quality Management and regulatory affairs. Point of contact between the responsible countries, HQ and Asia regional office in ensuring processes and local activities meet the respective country's regulatory and legal requirements. Management Representative for the company. To be involved in Management review committee and an Executive Board member. - Drives resolution of issues. Communicates issues, impact and outcomes to the management team. - Responsible for ensuring compliance to the submission standards, procedures and policies in India. Author and refine technical documentation necessary to maintain our current CE Markings and to complete a design dossier suitable for submission for new products. Maintain and monitor our quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS, continuous improvement, trend analysis, etc. Train all employees to the QMS, and assess skills, knowledge and QMS application. Perform internal audits to assess the company compliance with our QMS. Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information. Work with our Notified Body to maintain current certifications Qualifications 10 years of QMS experience and demonstrated leadership experience. 10+ years of experience in regulatory affairs and quality assurance in the healthcare industry Extensive experience hosting regulatory inspections and interacting with regulators Strong understanding of global registration requirements and demonstrated track record of successful market access. General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices Proven ability to create culture of accountability and ownership Proven track record with establishing and maintaining strong internal and external partnerships. Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. Highly independent and self-motivated and integrates well within a team. Ability to prioritise and make decisions. Good problem-solving abilities able to identify salient issues, consider alternative solutions and evaluate the most appropriate course of action. Strong organisational and team-working skills including commitment and flexibility. Sound work ethics. Looks beyond boundaries of own job to support others. Education Bachelors degree required in a science, engineering field or related discipline. Masters/MBA is a plus

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.

Responsibilities: * Prepare documentation according to ISO 13485 standards. * Ensure compliance with EU MDR, US FDA & CDSCO guidelines. * Maintain regulatory documentation * Internal Audits

Key responsibilities Prepare and submit applications via the SUGAM portal (Form 41 & 46) to relevant authorities (DCGI, IVRI, Krishibhavan, and DAHD) for veterinary products. Compile, review, and prepare CTD/eCTD dossiers for veterinary vaccines and APIs in compliance with CDSCO and international guidelines. Handle end-to-end veterinary product registration, including new applications, renewals, updates, and query responses. Track application status, follow up with authorities, and ensure timely responses to regulatory queries and deficiencies. Support audits by CDSCO and other bodies; maintain organized, inspection-ready documentation and records. Review and approve product Labelling and packaging to ensure regulatory compliance Review change control, assess PAC applicability, and prepare related submissions. Collaborate with R&D, QA, QC, Manufacturing, and Marketing to gather technical documents and provide regulatory inputs. Review technical documents and guide internal teams on regulatory standards, including new drug applications. Stay updated on evolving veterinary regulations and support the HOD in regulatory planning and decision-making. Skill Requirement Strong understanding of Indian regulatory frameworks including CDSCO. Must have experience with the SUGAM portal and CDSCO online submission process. In-depth knowledge of Form 41 and Form 46 requirements. Dossier preparation expertise for veterinary vaccines. Ability to interpret and apply regulatory guidelines accurately. Excellent communication, coordination, and project management skills. Job Location: Kadi,Gujarat (Bus transport facility available from Ahmedabad,Kalol & Kadi) Note: Immediate Joiner will be preferred first

Roles & Responsibilities Will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders. will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department. will be responsible for regulatory submission process, including CT-NOC, marketing authorization applications, NOC & test license. will follow up with regulatory agencies to obtain the approvals to support the regulatory timelines will identify and assess regulatory risks associated with product filing. will provide regulatory guidance to company personnel throughout the research and development process. Competencies: Understanding of various regulatory requirements for new drug development Presentation & Communication Skills Interpersonal Skills Proficiency in Kannada Desired Profile : M. Pharm/M.Sc. with 2+ yrs of experience in submission of dossiers to Indian Regulatory agencies Working experience of IND and NDA filing of NCE and NBE products

To oversee and manage all aspects of the QMS to ensure compliance with global regulatory standards, including the CDSCO requirements. Job Location : Chamarajpet, Bengaluru.

Role & responsibilities QA Documents Preparation, review, & revision (such as Work Instructions, Flowcharts, SOPs, Inward Quality Plan, Technical Data Sheet, Formats, etc.) Document Control (Soft copy & Hard copy) Coordinate with QC, Production, Design team & management. Maintain master copy & distribute control copy of documents to respective departments. Gain knowledge regarding medical device applications. Developing and implementing quality systems: Including policies, procedures, and guidelines, to ensure that products or services meet the required quality standards. Conducting audits and monitoring processes to ensure that they comply with quality systems and standards. Handling Customer Complaints Handling Corrective Action & Preventive Action (CAPA). Suggest & implement new document/ process/ system. Preferred candidate profile Should be a Graduate of Biological Science. (Bsc & Btech Biotechnology) Minimum 1 to 2 years of relevant experience required Certified internal auditor for ISO 13485;2016. Experience working with 3D printers in the healthcare segment. Strong organisational skills that reflect the ability to perform and prioritise multiple tasks seamlessly with excellent attention to detail.

Job Title: Senior Manager- Logistics Department: Logistics / Supply Chain Management Location: Vashi / Head Office Reports To: Logistics Head Job Description: We are seeking a highly experienced and motivated Senior Manager Logistics to oversee end-to-end international trade operations, including import/export logistics , regulatory compliance , and banking documentation . The ideal candidate will bring a deep understanding of DGFT, CDSCO, Customs, and global trade regulations. Key Responsibilities: Manage import/export logistics for raw materials, capital goods, and high-seas trade. Handle customs clearance , DGFT documentation , MEIS/RODTEP claims, and AD Code registrations. Coordinate with CHA agents , ports (JNPT, Sahar), and international banks. Ensure timely and accurate filing with regulatory authorities (CDSCO, FDA, PHARMEXCIL, IMC). Liaise with DGFT, CDSCO, GST, MPCB, RBI, FEMA and other regulatory bodies . Attend hearings and manage legal responses (customs, GST, ED disputes). Work with banks for LCs , bill discounting, foreign payments, and remittance documentation. Collaborate with internal teams (Finance, Purchase, Admin, QA/RA) for smooth logistics operations. Ensure accuracy and timeliness in quarterly filings, license renewals, and logistics reporting. Candidate Profile Experience: 5-10 years in international logistics, import/export operations, and regulatory compliance. Knowledge of: DGFT, CDSCO, Customs, RBI/FEMA, GST, MEIS/RODTEP schemes. Tools: ERP systems, MS Office, ICEGATE, DGFT & CDSCO portals. Skills: Leadership, Coordination, Documentation, Negotiation, Communication. Why Join Us? Be part of a leading chemical & pharmaceutical organization . Engage in challenging, cross-functional international operations . Work in a compliance-driven and growth-oriented environment . Apply Now If you're passionate about managing logistics operations and working in a high-impact role apply on Naukri or send your resume to hrd@calyxindia.com and become a part of the Calyx growth journey!

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name

#Hiring Regulatory Affairs Manager for one of the reputed MNC into Healthcare industry. Position Title: Regulatory Affairs Manager Location: Gurugram About Role:- The Regulatory Affairs Manager will be responsible for managing the regulatory strategy and ensuring the compliance of medical devices/IVD with applicable regulations. The candidate should have relevant years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, MDR 2017& BIS. This role involves working closely with cross functional team. The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to maintain product marketability in India. Key Accountabilities:- Provide Regulatory Support for timely new product launches. Well versed with filing application of Import Registration/Import license/Test License on SUGAM portal and NSWS & BIS Regulations & Certification. Stay abreast of regulatory procedures and changes in regulatory climate. Responsible for managing BIS application and submission procedures To review Medical Device dossier and technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents and take appropriate actions to obtain regulatory approvals as planned. Address queries from CDSCO/NSWS on submitted applications, provide regulatory support and assist in preparing a response to regulatory authoritys questions within assigned timelines. Responsible for managing modifications to a device after it has received regulatory approval. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Timely tracking and reconciliation of routine submissions/activities/Query response Post-Market Surveillance: Manage post-market surveillance activities, including adverse event reporting, field safety corrective actions, and vigilance reporting. Minimum Knowledge & Experience required for the position: Bachelor's/ Masters degree in a relevant field, such as life sciences, or regulatory affairs. Around 5+ years of relevant experience in Healthcare Industry (Medical Devices/IVDs) in Regulatory Affairs (MNCs) is desirable. Skills & Capabilities: Hands-on experience with the NSWS/ SUGAM portal and CDSCO online submission process. Strong understanding of Indian regulatory frameworks including CDSCO & BIS. Attention to detail and critical thinking skills Ability to work collaboratively with cross-functional teams. Note:- Looking Male candidate with decent exposure into RA role with reputed MNC's. If above role matches with your experience & aspirations than share CV to: recruit.corp12@apexservices.in