Senior Regulatory Affairs Officer

Senior Regulatory Affairs Officer - Vapi Gujarat We are seeking a highly experienced and proactive Senior Regulatory Affairs Officer to join our team in Vapi Gujarat. The ideal candidate will possess a strong background in regulatory affairs and a proven track record of success in preparing and submitting regulatory dossiers. This is a full-time permanent position that offers a professional and formal work environment. Job Title: Sr. Regulatory Affairs Officer Finished Formulations Experience: 3 to 6 Years Qualifications: B. Sc/ M. Sc- Organic Chem. Or B. Pharma / M. Pharma (Preferable) Location: Vapi - Gujarat Client is a leading specialist in Active Pharmaceutical Ingredients (APIs). We are a part of 50 year-old group currently exporting to 70 countries worldwide. The company has received global FDA accreditations from several countries including the USFDA EDQM and the FDA of Russia China Japan Mexico Brazil the UK Australia and Canada. Job Responsibilities: Compilation and review of regulatory dossiers (CTD ACTD eCTD) for CIS LATAM (especially Brazil & Mexico) African and EU regions. Handle full lifecycle of product registration including new submissions renewals and variations. Review technical documentation: PDR DMF AMV BMR/BPR Specifications Stability Reports BE Studies etc. Address Ministry of Health (MoH) queries and manage deficiency responses. Manage post-approval changes and variation submissions. Liaise with international regulatory agents and distributors for submission coordination. Artwork review and approval ensuring compliance with label regulations. Maintain up-to-date registration database and submission tracker. Prepare administrative documents: POAs LOAs legalization support etc. Conduct compliance review for change controls tech transfer documents and CMO data. Support site registration and GMP audits when required. Review and finalize Quality Agreements with partners/clients. Handle pharmacovigilance documentation (via third-party support). Preferred Skills & Experience: Expertise in CIS LATAM EU and African regulatory landscapes. Strong understanding of regulatory systems (e.g. UKMHRA EMA ANVISA CDSCO). Prior QC/analytical lab experience (esp. with HPLC) is a plus. Proficient in regulatory writing and dossier compilation independently. Strong coordination analytical and document management skills.