114 Cmc Jobs

Provide technical and scientific leadership to support upstream processes for early-stage development to ensure seamless handover to commercialization and life-cycle management of Sun s Branded Portfolio products manufactured internally and by a third-party suppliers/vendors. Contribute quality input into CMC strategy and execution to ensure robust supply and advance the company s portfolio. Represent and perform quality oversight duties in process development, characterization, scale-up, validation, tech transfer. Representation at Project Team and CMC meetings to plan for Clinical trial materials and collaborate with teams for handover to Commercial QA and manufacturing Provide scientific leadership in functional area to support process, product investigations (including excursions) and troubleshooting. Provide technical expertise and leadership to identify opportunities, oversee experimental planning and design, and analyze / trend, interpret, and document development results and review manufacturing data. Authoring and review of CMC documentation for regulatory filings. Responsible to support health agency and QP queries and inspections. Be an active engaged team member of the Development Quality team, support Management Review, represent Development QA in functional area meetings, as appropriate. Other tasks and audits to be performed as assigned by Management. Qualifications / Educational Requirements MS or PhD in chemical/biochemical engineering, biochemistry, or related area with 10+ years of relevant experience. Skills / Experience Requirements Proven record of quality - technical manufacturing experience; ability to influence and drive technical quality rigor; capability for strategic analysis and issue resolution Proven ability to work in a fast-paced environment with demonstrated capacity to manage multiple projects, tasks, timelines and demands Experience risk-based approaches in decision-making related to development, characterization, and manufacturing of drug products, devices and/or biologics. Demonstrate a collaborative teamwork and strong interpersonal skills Demonstrated ability to communicate appropriately and effectively Demonstrated organizational and project management skills working in a matrix environment. Experience performing audits in global regions is a preferred. VISA to travel to US and/or EU countries is a plus.

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization. JOB RESPONSIBILITIES : ;;;;;;;;;;;;; Accountabilities;;;;;;;;;;;;;;;;;;;;;;;;;;; Scope of work US Drug Dossier Authoring, Reviewing and Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation and Submission Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan and complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination Interface with R and D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R and D/ADL against DMF/Dossier requirements Reporting and Maintenance Maintain regulatory files/database

Summary The Technical Project Leader will, jointly with the CMC team, lead and manage all technical development activities for assigned small molecule projects within Technical Research & Development (TRD); represent TRD as core member in global project teams to define the global CMC strategy for the development, submission, approval and life cycle management of a product(s); maximize the support to local programs and partners; lead CMC teams with strong strategic focus, quality & environmental awareness, management capabilities, scientific and technical expertise; act as the TRD representative in complex projects involving external partners and/or highly innovative projects/processes. About the Role Major accountabilities: Performs strategic planning of more complex and/or accelerated projects with e.g., multiple candidates / scenarios, or of several projects with varying timescales. Has sense of urgency, aligns, and coordinates multiple activities in complex plans. Establishes realistic project timelines to achieve milestones and goals, organizes additional resources if needed to fulfill planning, tracks progress and takes actions if obstacles emerge or priorities change. Establishes technical development plans in line with priority classification of project, gated by clinical readouts as appropriate and with an enterprise view in consideration of overall portfolio priorities. Establishes high level summaries for presentation to management and stakeholders. Has advanced skill to identify, assess, manage, and communicate CMC risks / program risks. Due to seniority and experience, can handle more difficult risks, issues in more complex projects and handle multiple risks of DS/DP/Device even with junior CMC team members. Provides drug development expertise in addition to technical expertise. Follows standard process but at the same time thinks outside the box based on existing knowledge. Challenges the status quo, is curious and fosters creativity of team members and own creativity. Leverages existing knowledge and implements in EPT/GPT strategy. Continues to follow and stands behind EPT/GPT decisions. For complex late phase programs, Senior TPL supports defined work packages. Build relationships by identifying common interests and priorities with a variety of people inside and outside the organization. Has deeper understanding of current organizational structure, establishes networks and uses own network to resolve challenging situations and manage/drive change. Participates in boards and joins and/or can lead discussions in leadership teams. Is highly skilled in collaborative settings (i.e., external vs internal, CROs, DDs, in-/out-licensing settings). Approaches/analyzes issues and collaborates with other line functions for optimal solutions. Takes into account multiple stakeholder perspectives and approaches to find optimal solutions and build commitment and consensus. Provides knowledge of industry, main competitors, customers and external environment - this includes healthcare industry and global industry, digital and technological advancements. Shares knowledge with CMC community, e.g., by lessons learned sessions. Uses knowledge and experience to challenge and influence CMC line functions and/or EPTs/GPTs in background of the overall drug development strategy / industry insight. Actively contributes to EPTs/GPTs beyond CMC line functions. Is able to navigate and manage the complexity of the dis-ease area GPTs. Leads DDs for assets in development. Is able to cope with time pressure and senior management exposure. Relates to people in an open, friendly, and accepting manner. Understands the formal and informal channels for exchange of ideas and provides constructive feedback. Reacts tactfully when receiving advice, instruction or critical feedback and openly gives and receives feedback. Remains calm and objective and demonstrates respect, composure, and professionalism during difficult circumstances, including difficult interpersonal situations. Learns to manage teams/stakeholders appropriately (utilizing their support). Brings forward sound proposals and shares lessons learned, without passing the blame. Anticipates setbacks and stays in control - takes criticism as intended for situations (not personally or toward particular individuals). Recovers quickly from problems and setbacks. Exhibits servant leadership and provides mentoring/coaching to junior TPLs, line functions and CMC team members to support their professional and personal growth. Leads by example and drives decisions. Minimum requirements Successfully demonstrated several years (minimum of 2-3 years) of directly related experience as functional project leader and relevant experience as Associate TPL or equivalent. Has strong scientific/technical knowledge, understands technical development tasks. Is able to establish/maintain DS/DP/Device supply plan (in alignment with CSPL). Has fundamental knowledge of GMP and regulatory requirements. Has fundamental cross-functional knowledge (PK/PD, tox, clinical, commercial) regarding drug development. Manages end to end technical drug development and knowledge. Completed basic project management training. Potential extension (not mandatory): Basic/Bronze IQP training. Is adept at using and regularly uses/updates project management tools available in TRD (e.g. Gantt charts, MS Project, Resource Cockpit). Knows fundamental IT tools. Has effective presentation skills.

To provide timely and quality service to our customers during breakdown To Install, test FMC products and train the user as per the guidelines. To carry out preventive maintenance as per the schedule. To document all service and installation activities and update in CRM To generate AMC / CMC revenue with timely payment collection. To train and guide the juniors in the field.

Hiring for leading MNC company Interview Mode: Face-to-Face Interview Location: Noida & Gurgaon Exp Req: 0 to 5 Yrs Qualification: BPT, MPT, BUMS, BAMS, BHMS only Key skills: Claim Processing, Knowledge of Healthcare and coding, Knowledge of health insurance, CPT, CMC Work mode: WFO 5 days working Weekends fixed off Cabs available Salary: up-to 5 LPA Interview Dates: Gurgaon: 12/7/2025 (Saturday), 15/7/2025 (tuesday) Noida: 15/7/2025 (tuesday) Interested candidates call or WhatsApp on this number: 8700871235. Share your Cv on this email: amanaxisconsulting@gmail.com

Job Vacancy Location : Padi, Mahindra World City & Madurai. Qualification : B.E (Mech) /Automobile. B.E (EEE), B.E (ECE) B.Tech (Mech) / Automobile B.Tech (EEE), B.Tech (ECE) Job Description Maintenance Engineer (Machanical / Electrical) : Looking for Maintenance Engineers (Mechanical/Electrical) with hands-on experience in machinery upkeep and breakdown maintenance. Should be skilled in preventive maintenance, troubleshooting, and root cause analysis. Knowledge of hydraulics, pneumatics, and electrical systems is essential. Ability to handle shift-wise responsibilities and coordinate with the production team. Familiarity with TPM, 5S, and safety standards preferred. Interested candidate can WA your Resume 9003268049

Job Summary: We are looking for a motivated and enthusiastic Sales & Service Coordinator to provide commercial support and help our customers by responding to their requests for service contracts and spares in a timely and efficient manner. The ideal candidate should have strong soft-spoken communication skills , the ability to build relationships with customers , and be target-oriented . The role involves traveling as per business requirements to meet clients and ensure seamless service coordination. Key Responsibilities: - Achieve quarterly sales targets assigned by the company. - Prepare and follow up on quotations for spares, consumables, and service contract agreements. - Coordinate with customers for purchase orders of required spares and service contract agreements. - Prepare purchase orders and ensure timely procurement. - Communicate effectively with clients, engineers, and technicians to ensure smooth service delivery. - Schedule and attend meetings with customers for service agreements and spare accessories. - Build and maintain strong relationships with customers to enhance service engagement. Requirements: - Bachelors Degree / Diploma in a relevant field. - Preferred male candidate. - Soft-spoken communication skills with the ability to engage effectively with customers. - Proficiency in MS Excel for reporting and data analysis. - Target-oriented approach to achieving sales goals. - Ability to multitask and manage multiple requests efficiently. - Professional attitude and ability to remain composed under pressure. - Willingness to travel as per business requirements. Job Types: - Full-time, Regular / Permanent, Fresher can apply Benefits: - Cell phone reimbursement - Commuter assistance - Health insurance - Paid time off - Provident Fund Work Schedule: - Day shift / Morning shift (Mon to Sat. 09:30am to 06:30pm) Relocation & Commute: - Shivajinagar, Pune - 411005, Maharashtra: Must be able to reliably commute or be willing to relocate before joining. How to Apply: Interested candidates can send their resumes to adminhr@vihaanenterprisesindia.com

JOB PURPOSE As a Plant Purchase Manager located at Ambernath Plant, you will play a pivotal role in managing the procurement and sourcing activities for plant. Your expertise in vendor management, negotiation, and supply chain optimization will be critical in ensuring the smooth functioning of plant operations. You will collaborate closely with various departments to meet production requirements while maintaining cost-effectiveness and quality standards. KEY RESPONSIBILITIES Monthly planning & reporting, exception reports Purchase of indirect materials, contracts, agreements Ensuring the Material master's in system are updated. Review POs, Reduction of Lead Time, co-ordination with other depts. Oversee Imports formalities & documentation, Preparation for audits & compliance, Import purchase & Incoterms Negotiation with vendor and developing new vendors, effective vendor Management Reduction of Inventory with a cost focus, Cost optimization of usages and other spares inventory. RM Planning & Purchase as per Production forecast MRO Purchase Uses of online Auction Responsible for AMC, ARC & CMC NATURE OF EXPERIENCE Proven experience as a Purchase Manager or similar role within a manufacturing environment. In-depth knowledge of procurement best practices, sourcing strategies, and supply chain management. Strong negotiation skills and the ability to build and maintain positive relationships with suppliers. . Experience of working in a unionized workforce will be an added advantage . Should have experience of dealing with locals and villagers around plant locations. SPECIFIC SKILLS/PERSONAL ATTRIBUTES Familiarity with ERP systems and procurement so ware. Excellent analytical and problem-solving skills. Ability to work collaboratively across different departments and levels of the organization. Strong organizational and me management abilities to handle multiple tasks and deadlines effectively. Sound understanding of relevant regulations and legal requirements related to procurement Qualification: BE / B.Tech and Masters in SCM Experience 10-12 years,

Dear Candidate, Job opening at Paras Health Care Ltd Position - Senior Executive - Biomedical Experience Required - 0 To 4 Years Salary Range - As per Market Standard Experience & Qualification Diploma/ Degree in relevant Specialization (ITI, B.Sc - Instrumentation, B.E, B.Tech - Electronics, Biomedical, Instrumentation) Fresher or with an experience of 4 years. Specific Responsibilities The responsibilities are as follows: To coordinate and evaluate the work performed by service contractors including maintenance, calibration, installation and verification of service documentation. To monitor monthly schedule of plan preventive maintenance & calibration. To provide training for related facility staff on maintenance and utilization of equipment's. Renewal of AMC / CMCs of medical equipment's. Indent approval. Monitor complaint register / History card. To supervise staff in repair & maintenance. To negotiate with vendors regarding repairs. Ensures 90 % uptime for all medical equipment's Downtime should not more than 72 hours except major breakdown. Provides critical inputs which help decision making for procurement of various medical equipment's. Effective evaluation of new equipment specifications technological advancement of the hospital. Planning, distribution and costing, negotiating and all the other activities associated with setting up/starting a new facility. Perform any other duty that may be assigned from time to time. Skills: biomedical engineering,opto-mechanical engineering,medical equipment,amc,cmc,instrumentation,maintenance,

Provide technical support, troubleshoot issues, & ensure customer satisfaction Perform preventive maintenance, document service activities, & coordinate with the sales team Manage AMC/CMC contracts, ensure customer satisfaction. Required Candidate profile Minimum of 2-3 years of experience in servicing IVD instruments or similar medical devices Strong technical skills in instrument installation, troubleshooting & maintenance.

Profile: Medical Lab Incharge Onsite and Permanent Job description: Roles and Responsibilities: - Authorize release of test report based on the Buyers protocol & test methods - On time responds to Buyers & clients queries, emails and calls - Responsible for reviewing revisions, updates on test parameters, protocols and regulations, etc. and circulating these to the concerned lab team - Training lab staff as per updated, revised protocol received from clients and brands - Support team to develop capability on new test parameters as received in buyer protocol - Training & Supervising the handling, operating and maintenance of test equipment. - Supervising preparation and maintenance of document as per requirement of ISO 17025 - Monitor accuracy of ILC/ PT programs and timely delivery of Test results and Test reports - To monitor NABL and Buyers/ clients accreditation process & correlation activities - Responsible for efficient operations of testing lab. - Responsible for on-time delivery of test reports and maintaining TAT - Responsible for development of new test methods required as per revisions and updates - Seek approvals for revision of test reports, Invoices - Ensure AMC/ CMC for test instruments, Calibration tools, standard reference materials are in place. - Coordinate with QM/ Quality executive to respond and resolve customer complaints / claims, non-conformances and in the corrective and preventive action

Profile: Medical Lab Incharge Onsite and Permanent Job description: Roles and Responsibilities: - Authorize release of test report based on the Buyers protocol & test methods - On time responds to Buyers & clients queries, emails and calls - Responsible for reviewing revisions, updates on test parameters, protocols and regulations, etc. and circulating these to the concerned lab team - Training lab staff as per updated, revised protocol received from clients and brands - Support team to develop capability on new test parameters as received in buyer protocol - Training & Supervising the handling, operating and maintenance of test equipment. - Supervising preparation and maintenance of document as per requirement of ISO 17025 - Monitor accuracy of ILC/ PT programs and timely delivery of Test results and Test reports - To monitor NABL and Buyers/ clients accreditation process & correlation activities - Responsible for efficient operations of testing lab. - Responsible for on-time delivery of test reports and maintaining TAT - Responsible for development of new test methods required as per revisions and updates - Seek approvals for revision of test reports, Invoices - Ensure AMC/ CMC for test instruments, Calibration tools, standard reference materials are in place. - Coordinate with QM/ Quality executive to respond and resolve customer complaints / claims, non-conformances and in the corrective and preventive action

Christian Medical College is looking for Senior Resident / Assistant Professor to join our dynamic team and embark on a rewarding career journey Patient Care: Provide comprehensive medical care to patients under the supervision of attending physicians Perform physical examinations, diagnose medical conditions, develop treatment plans, and monitor patient progress Clinical Supervision: Supervise and provide guidance to junior residents, interns, and medical students in their clinical duties Assist in their training, evaluation, and professional development Hospital Rounds: Conduct regular hospital rounds to assess patients, review test results, and discuss treatment plans with the healthcare team Coordinate and communicate patient care plans with nurses, specialists, and other healthcare professionals Medical Procedures: Perform or assist in various medical procedures, such as venipuncture, wound care, suturing, and bedside procedures Ensure adherence to sterile techniques, safety protocols, and best practices Medical Documentation: Maintain accurate and up-to-date medical records, including patient history, physical examination findings, treatment plans, and progress notes Ensure compliance with legal and regulatory requirements Patient Education: Educate patients and their families about their medical conditions, treatment options, and preventive measures Provide counseling on lifestyle modifications, medication management, and post-discharge care instructions Interdisciplinary Collaboration: Collaborate with other healthcare professionals, including nurses, pharmacists, therapists, and social workers, to ensure coordinated and holistic patient care Participate in interdisciplinary team meetings and contribute to care planning Continuity of Care: Facilitate smooth transitions of care between inpatient and outpatient settings Coordinate follow-up appointments, referrals, and discharge planning to ensure continuity of care and optimal patient outcomes Medical Research and Education: Stay updated with the latest medical advancements, evidence-based practices, and clinical guidelines Engage in research activities, present at conferences, and contribute to medical education and scholarly activities Quality Improvement: Participate in quality improvement initiatives to enhance patient safety, clinical outcomes, and healthcare delivery Identify areas for improvement, implement evidence-based practices, and contribute to quality assurance programs Professional Development: Engage in continuing medical education (CME) activities, attend conferences, and pursue opportunities for professional growth Maintain licensure and board certification requirements

Role & responsibilities : Extend support on the compiling, submission and approval of Country Specific Submissions files for the responsible countries (NDA, LCM & post approval changes) Participate and extend support during initial submission planning Review & update the list of documents required for the submission (e.g., NDA, variation, tenders) Manage compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals and changes Preferred candidate profile :

Provide technical support, troubleshoot issues, & ensure customer satisfaction Perform preventive maintenance, document service activities, & coordinate with the sales team Manage AMC/CMC contracts, ensure customer satisfaction. Required Candidate profile Minimum of 2-3 years of experience in servicing IVD instruments or similar medical devices Strong technical skills in instrument installation, troubleshooting & maintenance.

Provide technical support, troubleshoot issues, & ensure customer satisfaction Perform preventive maintenance, document service activities, & coordinate with the sales team Manage AMC/CMC contracts, ensure customer satisfaction. Required Candidate profile Minimum of 2-3 years of experience in servicing IVD instruments or similar medical devices Strong technical skills in instrument installation, troubleshooting & maintenance.

Provide technical support, troubleshoot issues, & ensure customer satisfaction Perform preventive maintenance, document service activities, & coordinate with the sales team Manage AMC/CMC contracts, ensure customer satisfaction. Required Candidate profile Minimum of 2-3 years of experience in servicing IVD instruments or similar medical devices Strong technical skills in instrument installation, troubleshooting & maintenance.

Provide technical support, troubleshoot issues, & ensure customer satisfaction Perform preventive maintenance, document service activities, & coordinate with the sales team Manage AMC/CMC contracts, ensure customer satisfaction. Required Candidate profile Minimum of 2-3 years of experience in servicing IVD instruments or similar medical devices Strong technical skills in instrument installation, troubleshooting & maintenance.

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products Collaboration with partners to develop and execute global regulatory activities DMF preparations, review of changes and routine updates to Global Regulatory Agencies Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements Provide regulatory direction on global regulatory requirements to support product development Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle Support development and execution of clinical/non-clinical strategies Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans With minimal supervision, participate in development of risk management and contingency planning Ensure and lead regulatory compliance for biosimilar products Participation in regulatory meetings with Health Authorities Regulatory Intelligence: Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products Review and assess impact of regulatory decisions for competitive products Generate and communicate biosimilar intelligence Collaboration: Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products Identify process needs to meet internal challenges Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and Skills Comprehensive understanding of Regulatory activities Regulatory experience with product filings Team skills, especially in working with internal and external partners Familiarity with project management requirements Ability to understand and communicate scientific CMC information Anticipate and prevent potential issues Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission Education Doctorate degree OR Master's degree

Apollo Pipes Ltd is looking for Area Sales Manager - Rajkot to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Syneos Health is looking for Regulatory Manager (CMC, EU & Japan/China) to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

Role & responsibilities Prepares the submissions (ANDAs, amendments, supplements including labeling, annual reports) to support commercial business and to be-in compliance to FDA regulations. Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Escalate the review findings for a timely resolution. Leads labeling development for product launches and ensures that all labeling meets company and US regulating health authority specifications. Initiate/Review change control process and coordinate with other departments to ensure timely implementation. Prepare, review and submit eCTD submissions. Collaborates with Regulatory Affairs on submission and implementation strategy for labeling. Create and revise labeling. Proofread and verify all labeling to ensure accuracy and conformity with US FDA regulations. Prepare final printed labeling for FDA submissions (e.g. PDF, SPL, PLR format). Perform Drug listing. Preferred candidate profile Strong understanding of FDA, ICH, CMC and labeling requirements through all phases of development and life-cycle of the product. Proven proficiency with relevant FDA/ICH regulations & guidelines for labeling development, implementation, and compliance requirements, and applies understanding to business situations. Proven effectiveness with stakeholders in the labeling system from content development through commercial supply. Actively supports the systems, processes, and operations for development of and changes to labeling, and assures compliance to those procedures.

Career Category Operations Job Description As an Associate, Regulatory Data Management you will help ensure the compliance of our regulatory data via the smooth compliant flow of information across our systems and processes. Roles & Responsibilities: Provide support on maintaining our Regulatory Information Management (RIM) system. Create and archive clinical trial, marketing application submissions and health Authority correspondence within the organisation RIM system. Serve as a point of contact between regulatory representatives, CMC, safety, partners and the submission management team. Provide support on creating, running and analysing reports for data streamline projects. Provide support within data management global team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods. Adhere to Amgen processes, policies, guidelines, SOPs and training documentations. Required Knowledge and Skills: Highly motivated, organised, and detailed oriented team player. Familiarity with regulatory procedures and filings. Familiarity with global clinical and regulatory health authorities requirements e. g. FDA, EMA, MHRA etc. Preferred Knowledge and Skills: Working knowledge of the Veeva Vault platform is preferred Basic Education and Experience: Master s degree and some directly related experience OR Bachelor s degree and 2 years of directly related experience OR Associate s degree and 4 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP .

Job Vacancy Location : Padi, Mahindra World City & Madurai. Qualification : B.E (Mech) /Automobile. B.E (EEE), B.E (ECE) B.Tech (Mech) / Automobile B.Tech (EEE), B.Tech (ECE) Job Description Quality Control Engineer Looking for experienced Quality Control candidates with strong knowledge of PPAP and IATF 16949 documentation. Must be capable of handling customer complaints, root cause analysis, and corrective actions. Responsible for monitoring in-process and final product quality as per standards. Should have hands-on experience in quality tools and report generation. Ability to face and support internal/external audits independently. Join our team to ensure consistent quality and drive continuous improvement. Job Description Maintenance Engineer (Machanical / Electrical) : Looking for Maintenance Engineers (Mechanical/Electrical) with hands-on experience in machinery upkeep and breakdown maintenance. Should be skilled in preventive maintenance, troubleshooting, and root cause analysis. Knowledge of hydraulics, pneumatics, and electrical systems is essential. Ability to handle shift-wise responsibilities and coordinate with the production team. Familiarity with TPM, 5S, and safety standards preferred. Trainee for Production-2023/2025 Qualification : B.E (Mech) /Automobile. B.E (EEE), B.E (ECE) B.Tech (Mech) / Automobile B.Tech (EEE), B.Tech (ECE) Location- Thiruvallur Interested candidate can WA your Resume 9003268049