73 Regulatory Documentation Jobs - Page 2

To ensure that products with all regulations and legislation, both National and international,throughout the product lifecycleThe RAP works closely with R&D manufacturing QA/QC and mkt to ensure timely registration,compliance and approval of products

The Candidate will be responsible to the Business Operations for Global as well as Developing New Business Opportunity by focusing on building and growing strong relationship both internally and externally. Devising effective Business Development Strategy for future research-based products with global Clients in Nutraceutical, Dietary & Natural/ Herbal Supplements for all categories. KEY DELIVERABLES: Strategic and Operational Excellence Identifying opportunities to build, develop and strengthen relationships with global clients to grow and sustain the business by strategizing optimum customer selection and management, team expansion and nurturing a healthy cross functional team culture. Identifying opportunity to increase presence by developing plan to make potential partnerships, enhance distribution and stepping into new markets and methods to enhance efficiency within the internal sales and support team. Identifying the business trend, plan and participate in key tenders to draw maximum business opportunity. Effectively design and assign target to the downline, taking periodic review for mid-way correction, provide clear direction to plan achieving the target and meet business objective. Accountable for maintaining a healthy P&L by over-viewing and devising effective strategy around setting correct pricing to quote, mobilizing of old stock, timely order placement to mitigate the risk of expiry of RM/PM, timely payment collection as per agreed terms. Overview and manage effective coordination with all internal stakeholders like PPIC, Logistics, RA, Finance and ensure best customer service experience is extended to overseas customers. Ensure the team adheres to company SOP by conducting periodic review/ audit and taking corrective measures for any deviation, guide the concern and being an enabler to maintain a healthy work culture and providing overall service excellence to customers. Customer Relationship Management Overview and ensure customer queries are handled properly. Overview clients feedback on any specific aspect, ensure devising a proper resolution to provide optimized customer experience and retention. Directly getting involved wherever needed to earn better customer loyalty and service assurance. Analysis & Reporting Maintaining database of prospects & provide weekly/monthly progress report to the leadership team for taking key decisions. Track and analyze data around competitors activities, IPMS/ Export/ Market Intelligence Reports, new opportunities, best practices and other changes in the industry to discuss and effectively develop business development/ expansion strategy. CANDIDATE PROFILE: Well versed with latest market trends in order to generate leads & building connections. Prefer MBA in International Business for this role. Having a strategic bent of mind with strong analytical ability. Having sound communication, leadership and interpersonal relationship skill. Having strong market contact in global market. Must be aware of current regulatory affairs related regulations.

Product Data Mining from regulatory data tools. Engaging with IT to backfill product data into ERP systems. Customer Support on regulatory document requests. Vendor engagement to obtain regulatory documents and data. Ongoing regulatory data analysis and tracking. Analysis of materials properties and compliance status. Support part / material sampling and testing process. Internal global stakeholder engagement in a regulatory support function as needed. Support product compliance with a myriad of current and imminent global regulatory obligations. Qualifications: College Degree (BS) in Chemical Engineering, Chemistry, Material Science or another related field. 3+ years of prior experience in a regulatory, product safety, component engineering, or data analyst role. Strong attention to detail / accuracy and excellent verbal / written communication skills. Demonstrated proficiency with MS Office tools - Excel, Access, PowerPoint, and Word. Experience with ERP tools such as Oracle. Ability to function effectively in a fast-paced environment while juggling multiple priorities. Excellent organizational skills, strong customer focus and professional demeanor at all times

Product Data Mining from regulatory data tools. Engaging with IT to backfill product data into ERP systems. Customer Support on regulatory document requests. Vendor engagement to obtain regulatory documents and data. Ongoing regulatory data analysis and tracking. Analysis of materials properties and compliance status. Support part / material sampling and testing process. Internal global stakeholder engagement in a regulatory support function as needed. Support product compliance with a myriad of current and imminent global regulatory obligations. Qualifications: College Degree (BS) in Chemical Engineering, Chemistry, Material Science or another related field. 3+ years of prior experience in a regulatory, product safety, component engineering, or data analyst role. Strong attention to detail / accuracy and excellent verbal / written communication skills. Demonstrated proficiency with MS Office tools - Excel, Access, PowerPoint, and Word. Experience with ERP tools such as Oracle. Ability to function effectively in a fast-paced environment while juggling multiple priorities. Excellent organizational skills, strong customer focus and professional demeanor at all times

Role & responsibilities Collaborate closely with the Submission Level Publisher to ensure timely and accurate document processing. Perform daily PDF processing tasks as per assigned workload and project requirements. Adhere strictly to submission timelines and regulatory deadlines. Conduct troubleshooting using ISI Toolbox, resolving technical issues efficiently to avoid delays. Execute quality control (QC) checks of PDF files, focusing on: Bookmarking Hyperlinking Table of Contents (TOC) accuracy Implement corrections in processed PDF files based on QC comments or review feedback. Escalate and communicate any processing issues to the Submission Specialist, particularly those involving ISI Toolbox. Ensure all files follow Amneal's internal file naming conventions for consistency and traceability. Actively participate in group activities and provide peer support within the team for eCTD submissions and related publishing tasks.

Qualification: MSc in Analytical / Organic Chemistry Pharmacy Life Science Role Summary: Seeking detail-oriented and motivated regulatory compliance specialists to manage and coordinate regulatory activities related to API filings across multiple regions. Responsibilities include preparing, reviewing, and submitting high-quality regulatory documents to ensure global compliance. Key Responsibilities: Prepare, compile, and submit DMFs, ASMFs, and API regulatory dossiers to global authorities. Ensure timely updates, maintenance, and life cycle management of submissions. Monitor global regulatory changes and communicate to internal teams. Handle customer queries, letters of access, and technical data packages. Maintain database and tracking systems for submissions and commitments. Support regulatory and customer audits across all sites. Key Skills & Competencies: Passion to make a difference combined with : Strong analytical and strategic thinking. High attention to detail and ability to manage multiple projects/filings. Excellent written and verbal communication. Experience with Electronic Submission System (eCTD). Knowledge of pharmaceutical standards (USP, EU, JP). Understanding of documentation and filing requirements (US-FDA, EDQM, ANVISA, PMDA, etc.). Familiarity with ICH Q7, M7, Q11, Q12 guidelines.

Primary Skills SAP PLM Recipe Development & Management Extensive experience in configuring and managing end-to-end recipe development processes within SAP PLM. Proficient in creating and optimizing formulas, defining ingredient compositions, and ensuring compliance with industry-specific regulations. Strong understanding of managing recipe versions, tracking modifications, and maintaining historical records for transparency and traceability. Specification and Compliance Management In-depth knowledge of handling raw material, intermediate, and finished product specifications. Ability to set up structured specification templates, define critical parameters, and ensure adherence to global regulatory and quality standards such as ISO, GMP, and HACCP. Expertise in managing allergen declarations, nutritional information, and safety data sheets within SAP PLM. Integration with Production & Quality Modules Hands-on experience in integrating SAP PLM Recipe with SAP PP (Production Planning), QM (Quality Management), and EHS (Environment, Health, and Safety). Ensures smooth data flow between product development, manufacturing, and quality assurance teams, enabling real-time collaboration and efficient production workflows. Labeling and Regulatory Compliance Strong understanding of managing labeling requirements, ingredient declarations, and regulatory documentation. Experience in configuring label templates, automating ingredient statements, and ensuring compliance with global regulatory bodies such as FDA (U.S. Food and Drug Administration), EU regulations, FSSAI (Food Safety and Standards Authority of India), and other industry-specific standards. Ensures that product labels accurately reflect composition, nutritional values, and allergen warnings. Workflow Automation and Change Management Expertise in streamlining and automating workflows for recipe approvals, change management, and version control. Proficient in setting up automated notifications, multi-level approval processes, and audit trails to enhance product development efficiency. Ensures that all changes to recipes, ingredients, and specifications are systematically tracked, approved, and implemented with minimal disruptions. Secondary Skills Experience with SAP PLM Web UI and Fiori applications for enhanced user experience. Understanding of SAP S/4HANA PLM functionalities and data migration from legacy systems. Knowledge of integrating SAP PLM Recipe with external LIMS (Laboratory Information Management Systems). Familiarity with PLM collaboration tools for cross-functional teamwork. Experience in troubleshooting PLM Recipe-related performance and data inconsistencies.

Role & responsibilities Regulatory Affairs Associate Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches Be the interface with health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser Provide guidance and knowledge sharing within the RAM skill group If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc. Minimum Requirements Education and Experience Relevant qualification and/or experience in science Minimum 5 years of experience from biopharmaceutical industry, or other relevant experience Proficient verbal and written English Project management skills Experience in document management and tracking databases Preferred Experience Some regulatory/medical/technical experience Knowledge of CLIENTbusiness and processes Some knowledge of CLIENT”submissions, compilation, publishing and approval processes, standards, systems and tools Experience of collaborating with people from locations outside of India, especially Europe and/or USA Skills and Capabilities Good written and verbal communication skills in English Cultural awareness Proficiency with common document management tools Ability to work independently and as part of a team Focus on continuous improvement and knowledge sharing Internal and External Contacts/Customers Lead RPM and members of the Global Regulatory Execution Team (GRET) and Global Regulatory Strategy Team (GRST) Other R&D skill groups, e.g., GRO, Operations Regulatory, Patient Safety, Reg TA (GRL & Regional Leads) Marketing companies Health authorities External collaboration partners “client” Legal “CLIENT”vendors for translation, document authentication, etc. Interested candidate Kindly drop your updated resume to below mail id Nithya_kumar@persolkelly.com Regards, Nithya CONFIDENTIAL NOTE: By submitting your resume or personal data, you acknowledge reading and agreeing to our Privacy Policy. You hereby provide voluntary consent to the collection, use, processing, and disclosure of your data by us and our affiliates, in line with the Privacy Policy. and applicable laws. If you wish to withdraw your consent or have any concerns, you may submit a request to our designated consent manager, as outlined in our Privacy Policy. We prioritize your privacy. SECURITY NOTE: We at PERSOLKELLY India or our representatives, do not ask job seekers for fees, personal banking information, or payments through unofficial channels. Official communications will only come from @persolkelly.com. Report any suspicious activity to Contactus_in@persolkelly.com. Click here to find out how you can safeguard yourself from job scams

Candidate Profile: Minimum qualification should be Graduate in Chemistry (Hons) 2-5 years experience in a chemical laboratory doing analysis or R&D work or having experience in any kind of chemical regulatory work Have good hold on English language Dynamic and disciplined Have ability to do lot of data search on the internet and refer books & journals Have the interest to study and read documents thoroughly to analyse and understand Open to travel both within India and outside related to office work Have the ability to work in team and believes in teamwork Innovative and takes initiative

. Role & responsibilities Knowledge on Medical device regulations Good Communication skills Ability to read through the Medical Device Documents Ability to work on Microsoft tools (Excel, Word and PowerPoint) Experience on Medical Device UDI Data management will be an additional preference Preferred candidate profile Work location: Madurai Education: B.E Mechanical/Bio-Medical Experience: 6 months to 3 yrs Immediate joiners are only preferred. Interested candidates can share your resume to keeshouley.m@hcltech.com. Interview Mode - Scheduled Walkin (Need to report to Madurai premises for Face to Face Interview). Regards, Keeshouley M

Preparation, review and compilation of assigned ANDA/NDA [505 b (2)]/projects for filing and knowledge of eCTD, Module 2 and 3. Hands on experience in reviewing CMC documents of Solid and Liquid Oral Dosage forms. Preparation, review and compilation of Supplements and Amendments. Review of Pharmaceutical Development Reports Review of manufacturing documents like batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, hold time study reports, master formula cards, master packaging cards etc. Review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer reports, dissolution protocols (multi point, multimedia and alcohol dose dumping etc), stability protocols and stability data

Associate - Clinical Quality Assurance (CQA) Department: QA - MakroCare and DDi Job Roles and Responsibilities: Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations. Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed. Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads. Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements. Conduct internal audits of Clinical Research Department activities and ISO requirements, ensuring compliance with ICH-GCP and company procedures. Provide training to staff on ISO standards and local regulations when necessary. Control and manage documents, including maintaining master lists and issuing change controls, deviations, CAPAs, amendments, and notes to file. Update logs for change control, deviations, CAPAs, amendments, and NTFs. Prepare annual CQA reports and trend analysis, and assist with external audits from clients, certification bodies, or regulatory authorities. Requirements: Education: Bachelor's or Master's in Life Sciences (or related field). Experience: 2-3 years of experience in Clinical Quality Assurance or related roles. Familiarity with ISO regulations, ICH-GCP guidelines, and QMS. Experience in conducting internal audits and maintaining regulatory documentation. Note: Additional responsibilities may be assigned by the Head of Department (HOD).

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

We are seeking an experienced professional to lead Quality Assurance while supporting Regulatory Affairs activities at our API manufacturing facility. The ideal candidate will be responsible for ensuring overall compliance with QMS and regulatory standards, managing validations and audits, and maintaining product quality in line with international guidelines. Key Responsibilities: Lead The implementation and oversight of the site Quality Management System (QMS), including SOPs, validations, and document control. Conduct and manage internal and vendor audits; review deviations, non-conformances, and ensure timely CAPA execution. Review and approve Master Production Records, Batch Production Records, and Validation Protocols across departments. Coordinate process, cleaning, and analytical method validations as per the Validation Master Plan. Prepare, review, and manage regulatory documentation including DMFs/ASMFs in CTD format (Modules 1, 2, 3). Liaise with regulatory authorities and customers for audit readiness, document submissions, and compliance queries. Oversee training programs for plant personnel and ensure continuous adherence to GMP standards. Conduct Product Quality Reviews and implement risk management tools like FMEA, HACCP, and HAZOP where applicable. General Requirements: Thorough understanding of global regulatory guidelines (ICH, WHO, USFDA, etc.). Strong analytical, documentation, and decision-making skills. Proficient in regulatory submissions and quality review documentation. Familiarity with stability studies and establishing expiry/retest periods. Hands-on experience with validation protocols and equipment calibration systems. Ability to lead cross-functional teams and ensure site-wide compliance. Excellent verbal and written communication skills. Willingness to take ownership and drive continuous improvement initiatives.

DEPARTMENT: Corporate Solutions As a member of the COSEC Team you will be expected to work in collaboration with other members of the Team, assist and support in providing administrative, compliance and regulatory services of to overseas client Companies, in accordance with applicable policies and procedures, regulatory requirements, service levels and company standards so as to satisfactorily meet client expectations. The Role: Understanding corporate and legal compliances as per jurisdiction in which client companies are located. Handling compliances and documentation under the applicable anti-money laundering regulations. Handling compliance relating to Board Meetings of overseas client companies as per applicable jurisdiction including scheduling of meeting, preparing agenda and compiling board packs and circulation of the same to directors. Handling compliances relating to annual meetings of overseas client companies. Attend Board Meetings and make notes for drafting board resolutions and minutes within applicable internal timelines and getting the same approved and signed by directors / Chairman. Updating / renewing all regulatory documents of the client companies including statutory registers, returns, registrations, licenses, certificates, insurance, etc. and filling up applications, forms and uploading / downloading of documents required for the same. Assisting the team in providing required documents for various purposes including banking and taxation requirements. Assisting in audits including internal audits and risk assessments and reviews. Maintaining and updating trackers as maintained by clients or internally and ensuring data integrity and confidentiality of internal and client information. Drafting and vetting of agreements, contracts and documents. Preparation of SOPs and training material for understanding and benefit of the team members. To provide administrative and regulatory support to Client Services Team as well as COSEC team as and when required. The Skills: Excellent drafting skills including drafting of agenda, resolutions, minutes, reports, agreements, etc. Ability to learn and grasp new compliance concepts and global compliances applicable to overseas clients. Strong work ethic. Adapting and flexible approach towards learning new systems and operational procedures. Ability to work under pressure and tight timelines, excellent time management and multi-tasking skills. Strong interpersonal, verbal and non-verbal communication skills. Team Player with excellent collaborative, analytical, problem solving and organisational skills. Result oriented, detail oriented, team player with ability to work effectively with minimum supervision, in a fast paced, complex and dynamic environment. Efficient MS Office skills (including MS Outlook, MS Word, MS Excel, MS PowerPoint) Qualifications Company Secretary;. Experience in handling compliances under Anti-Money Laundering Regulations will be an added advantage.

DEPARTMENT: Corporate Solutions As a member of the COSEC Team you will be expected to work in collaboration with other members of the Team, assist and support in providing administrative, compliance and regulatory services of to overseas client Companies, in accordance with applicable policies and procedures, regulatory requirements, service levels and company standards so as to satisfactorily meet client expectations. The Role: Understanding corporate and legal compliances as per jurisdiction in which client companies are located. Handling compliances and documentation under the applicable anti-money laundering regulations. Handling compliance relating to Board Meetings of overseas client companies as per applicable jurisdiction including scheduling of meeting, preparing agenda and compiling board packs and circulation of the same to directors. Handling compliances relating to annual meetings of overseas client companies. Attend Board Meetings and make notes for drafting board resolutions and minutes within applicable internal timelines and getting the same approved and signed by directors / Chairman. Updating / renewing all regulatory documents of the client companies including statutory registers, returns, registrations, licenses, certificates, insurance, etc. and filling up applications, forms and uploading / downloading of documents required for the same. Assisting the team in providing required documents for various purposes including banking and taxation requirements. Assisting in audits including internal audits and risk assessments and reviews. Maintaining and updating trackers as maintained by clients or internally and ensuring data integrity and confidentiality of internal and client information. Drafting and vetting of agreements, contracts and documents. Preparation of SOPs and training material for understanding and benefit of the team members. To provide administrative and regulatory support to Client Services Team as well as COSEC team as and when required. The Skills: Excellent drafting skills including drafting of agenda, resolutions, minutes, reports, agreements, etc. Ability to learn and grasp new compliance concepts and global compliances applicable to overseas clients. Strong work ethic. Adapting and flexible approach towards learning new systems and operational procedures. Ability to work under pressure and tight timelines, excellent time management and multi-tasking skills. Strong interpersonal, verbal and non-verbal communication skills. Team Player with excellent collaborative, analytical, problem solving and organisational skills. Result oriented, detail oriented, team player with ability to work effectively with minimum supervision, in a fast paced, complex and dynamic environment. Efficient MS Office skills (including MS Outlook, MS Word, MS Excel, MS PowerPoint) Qualifications Company Secretary;. Experience in handling compliances under Anti-Money Laundering Regulations will be an added advantage.

Key Deliverables: Prepare regulatory documents ensuring anonymization and redaction compliance Develop and maintain written redaction strategies for studies/products Coordinate with cross-functional teams for review and timely submission Support trend analysis and clinical disclosure process improvement Role Responsibilities: Interpret and apply clinical data within regulatory frameworks Follow SOPs and controlled processes for document preparation Manage timelines and priorities to meet disclosure deadlines Communicate and escalate document or strategy issues as needed

The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the bank's clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating Procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help execute trades. A dynamic and diverse division, our objective is to make sure that all our services are executed in a timely and professional manner, that risk is minimized and that the client experience is positive. We are proud of the professionalism of our people, and the work they do. In return, we offer excellent career development opportunities to foster skills and talent. In accordance with Anti-Money Laundering Requirements, banks, such as Deutsche Bank AG (DB), are obliged to perform Know-Your-Client (KYC) reviews on all new clients they adopt. These checks and reviews are made in strict accordance with regulatory requirements and the bank's internal policies. The project involves verification of the client data, performing due diligence checks on the clients, reviewing KYC documentation, performing the risk assessment of the client, liaising with the business/compliance, advising on KYC requirements and signing off on new client adoptions. The Reg & Tax analyst role is an operations function where you will be involved in reviewing various regulatory documents related to clients to ensure that all the regulatory requirements are met and the bank is in compliance. Your key responsibilities Responsible for verification of client data Perform due diligence of new and existing clients covering a wide range of different client types including: listed and regulated, small/medium/large private and public companies, as well as more complex structures such as SPVs, co-operatives, foundations and funds, governments, joint ventures, etc. Verifying KYC documentation of the clients to be adopted/reviewed Perform the risk assessment of the client to be adopted/reviewed Signing off on new client adoptions and periodic reviews Manage new client adoption or periodic review stream, to ensure that all requests are approved in accordance with regulatory requirements and the bank's internal policies Manage exceptions ensuring that all SLAs defined with the business on timeliness and quality are adhered Your skills and experience 6+ years of relevant work experience (AML/KYC/compliance related) within corporate financial services industry, research/analytics role in other banks / KPOs etc. Understanding of control, compliance, investigation/chasing functions in banks Familiarity with AML/KYC regulations and industry guidelines (FSA, JMLSG, 3rd EU Money Laundering Directive, MiFID) Ability to interpret regulatory guidelines and assess risk scores and entity types Ability to interpret alerts Ability to identify trends and inconsistencies Understanding of end-to-end KYC process

The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the bank's clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating Procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help execute trades. A dynamic and diverse division, our objective is to make sure that all our services are executed in a timely and professional manner, that risk is minimized and that the client experience is positive. We are proud of the professionalism of our people, and the work they do. In return, we offer excellent career development opportunities to foster skills and talent. In accordance with Anti-Money Laundering Requirements, banks, such as Deutsche Bank AG (DB), are obliged to perform Know-Your-Client (KYC) reviews on all new clients they adopt. These checks and reviews are made in strict accordance with regulatory requirements and the bank's internal policies. The project involves verification of the client data, performing due diligence checks on the clients, reviewing KYC documentation, performing the risk assessment of the client, liaising with the business/compliance, advising on KYC requirements and signing off on new client adoptions. The Reg & Tax analyst role is an operations function where you will be involved in reviewing various regulatory documents related to clients to ensure that all the regulatory requirements are met and the bank is in compliance. Your key responsibilities Responsible for verification of client data Perform due diligence of new and existing clients covering a wide range of different client types including: listed and regulated, small/medium/large private and public companies, as well as more complex structures such as SPVs, co-operatives, foundations and funds, governments, joint ventures, etc. Verifying KYC documentation of the clients to be adopted/reviewed Perform the risk assessment of the client to be adopted/reviewed Signing off on new client adoptions and periodic reviews Manage new client adoption or periodic review stream, to ensure that all requests are approved in accordance with regulatory requirements and the bank's internal policies Manage exceptions ensuring that all SLAs defined with the business on timeliness and quality are adhered Your skills and experience 6+ years of relevant work experience (AML/KYC/compliance related) within corporate financial services industry, research/analytics role in other banks / KPOs etc. Understanding of control, compliance, investigation/chasing functions in banks Familiarity with AML/KYC regulations and industry guidelines (FSA, JMLSG, 3rd EU Money Laundering Directive, MiFID) Ability to interpret regulatory guidelines and assess risk scores and entity types Ability to interpret alerts Ability to identify trends and inconsistencies Understanding of end-to-end KYC process

Seeking candidate with hands-on experience in compiling/reviewing ACTD & CTD dossiers, regulatory documentation, and timely submissions. Must coordinate with teams, follow regional guidelines, and manage multiple projects efficiently.

Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier compilation for ACTD & CTD is mandatory. Coordination with the external stakeholders for the preparation of the regulatory documents. To be responsible for the Life cycle management of assigned products. Should have experience for Life cycle management and license Maintenance. Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Desired Candidate Profile Candidate must have good knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Perks and Benefits Best in industry. Immediate Joiners preferred

Roles & Responsibilities: 1. Product Registration: Handle the registration of products under FDCA (Food and Drugs Control Administration) for necessary approvals. 2. Label Claim Verification: Coordinate with the Formulation & Development team to confirm and validate claims mentioned on product labels and the regulatory classification of each product. 3. Artwork Coordination: Work closely with the sales team to ensure that product artworks (for existing and new products) meet all relevant regulatory requirements. 4. Renewals & Compliance: Manage the timely renewal of product approvals under applicable regulatory bodies, maintaining full compliance throughout the product lifecycle. Qualifications: 1. Bachelors or master’s degree in pharmacy , chemistry, or a related field. 2. 1–2 years of experience in regulatory affairs (preferably in cosmetics, personal care, or pharma). 3. Good knowledge of FDCA and other relevant cosmetic product regulations. 4. Strong communication, coordination, and documentation skills. 5. Detail-oriented with a proactive approach to compliance and deadlines.

We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously.

Ensure documentation of Forest Clearance application & Wildlife Clearance application with consultant Ensure verification of DGPS & Toposheet maps required under application Ensure compliance with forest and wildlife regulatory frameworks throughout the clearance process. Assist in preparing reports and updates for project stakeholders and regulatory bodies.

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.