The role involves independent management of Vendor Qualification and audits, Liaisoning with FDA / FSSAI regulatory authorities, Contract Manufacturing site audits, Market complaint Investigation, Participation in customer Audits, self-inspection audits and support to site QA and R&D. Work Exp: 10 yrs - 15 yrs in Pharmaceutical sector having hands-on experience in Audit & Compliances. Key Responsibilities: To monitor & maintain Vendor Qualification status of Raw Materials and Packaging Materials as per SOP including arranging, reviewing and archiving the entire vendor qualification documents including Vendor Qualification, Technical Agreements, Audit reports and compliance. Planning of Vendor Audit Schedules and maintaining Approved Vendor Lists Vendor approval and linking of Vendor and Item codes in ERP based on VQ documentation and Production requirement Arranging for all vendor related documents as needed by Regulatory Affairs for registration purpose or as per customer requirements Co-ordination with Third Party testing Labs in case of any additional testing requirements for regulatory filings or customer requirements Market Complaint investigation and closure in coordination with Site QA Resolving product queries as raised by the customer teams from time to time Inspection and evaluation of all the Third party organizations used for Manufacture, Testing or for any other activity by Fullife. Ensuring CAPA compliance and verification Participating in FSSAI / FDA Audits, coordinating with FSSAI / FDA Officers for closure of the observations, attending to any queries as raised by FDA / FSSAI, visiting FA / FSSAI offices as per need Assisting and providing technical support to Cross functional teams like Site QA/QC/R&D/Mkt/Purchase/Legal in self inspections, finalization of agreements etc. International Drug Project Management. Travel to Manufacturing site at Khopoli every week and need basis. Qualifications: B. Tech/B.Pharm/ BSc / M. Pharm in QA Key Competencies: Have strong technical skills, strong communication skills with all the key stakeholders and external customers. Ability to evaluate and troubleshoot. Proactive, strong-minded, quick thinker and assertive. A mature and professional individual who is self-motivated and enthusiastic. Able to communicate with management, peers within the organization and customers. Auditing and compliance. Good Documentation Practices. Project Management.
The role includes developing and executing regulatory strategies, compilation and review of regulatory submissions, ensuring product compliance and acting as a key liaison with regulatory agencies. The role requires a deep understanding of regulatory guidelines, strong analytical and communication skills, and the ability to lead cross-functional teams in regulatory environments like pharmaceuticals and Nutraceuticals / Food supplements. Work Experience: 10yrs - 12yrs Qualifications: B.Sc. / M.Sc/ B.Pharm Key Responsibilities: Submission Management: Preparation, review and submission of regulatory documentation (e.g., dossiers, applications) to health authorities as below : Europe, South Africa, Australia Phillipines,West Africa (Senegal, Ivory Coast etc., for Drug products. Handling complementary medicines in Australia ( TGA ) FSSAI regulations for Nutraceuticals / Food supplements FSSAI License Application, Annual return filing and license maintenance Global Regulatory filing for Nutraceuticals / Food supplements Labelling including SPC’s / PIL Free sale certificate application Test License Application Import license / Registration for Cosmetics Compliance : Ensure products and processes consistently adhere to all relevant national and international regulations and standards. Regulatory Intelligence: Monitor and interpret changes in regulatory legislation and guidelines, providing actionable insights to internal teams and leadership. Cross-Functional Collaboration: Work with R&D, manufacturing, quality assurance, and commercial teams to align product development and lifecycle management with regulatory requirements. Documentation Management: Maintain accurate and comprehensive regulatory databases, files, and records. Proficiency in Online Portals: Ability to navigate and use the FOSCOS, SUGAM portal for application. Desired Candidate profile: In-depth knowledge of regulatory affairs for Drug products , Nutraceuticals / Health Supplements. Strong ability to analyze regulatory issues, trouble shooting and develop pragmatic solutions. Excellent verbal and written communication skills to effectively interact with regulatory bodies, internal stakeholders and external customers Strong organizational skills and the ability to manage multiple priorities and projects simultaneously. Working closely with CMO’s for regulatory submissions Ability to build relationships and work effectively with various internal departments In depth knowledge of Labelling (RDA ,Nutritional information , claims etc. in line with FSSAI and International Food agencies like EFSA etc) Preparation of labelling in line with the country requirement , review and finalization of artworks Tracking of the regulatory submissions, re-registrations, renewals Tracking of the FSSAI licenses, timely renewals Ensuring that the product is launched and commercialised as per the approved documents. Ensuring that any commitments to the Regulatory agencies are timely addressed