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.

experience

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