Job Title: Regulatory Affairs Officer
Company: West-Coast Pharmaceutical Works Ltd.
Location: Sola, Ahmedabad, Gujarat
About West-Coast Pharmaceutical Works Ltd.:
West-Coast Pharmaceutical Works Ltd. is a leading name in the Indian pharmaceutical industry. We are committed to excellence and are currently seeking a dedicated Regulatory Affairs Officer to join our team at our headquarters in Sola, Ahmedabad.
Job Summary:
We are seeking a highly motivated and experienced Regulatory Affairs Officer to manage and prepare regulatory documentation for our products. The ideal candidate will have a strong understanding of CTD/ACTD dossier preparation and regulatory requirements for regulated markets, including ROW and EU.
Key Responsibilities:
- Prepare and review CTD and ACTD dossiers for domestic and international submissions.
- Manage FDA documentation, including Product Permission (PP), COPP, and GMP certificates.
- Ensure compliance with regulatory requirements of ROW (Rest of World) and EU regulated markets.
- Coordinate with production, quality assurance, and R&D teams for dossier compilation.
- Track submission status and respond to regulatory queries.
- Maintain up-to-date regulatory files and databases.
Qualifications & Requirements:
- B.Pharm or M.Pharm (mandatory).
- 1 to 3 years of relevant experience in pharmaceutical regulatory affairs.
- Strong knowledge of CTD/ACTD dossier preparation and eCTD basics.
- Hands-on experience with FDA documentation (PP, COPP, FSC, etc.).
- Exposure to regulated and semi-regulated markets (EU, ROW, Africa, LATAM) preferred.
- Excellent communication and documentation skills.
What West-Coast Pharmaceutical Offers:
- Competitive salary package (best in the industry for the right candidate).
- Stable full-time employment in Ahmedabad.
- Opportunity to work with a reputed exporter to regulated markets.
- Supportive work environment with scope for learning and growth.
How to Apply:
Interested candidates should send their updated CV to [email protected] and contact 7041048158
Interview Venue:
West-Coast Pharmaceutical Works Ltd. Meldi Estate, Near Gota Chokdi, Sayona City Road, Sola, Ahmedabad, Gujarat
Note: Mention “Regulatory Affairs Officer Application” in the subject line for faster processing.
FAQs:
- Is this Regulatory Affairs job work-from-home or on-site? This is a fully on-site position at West-Coast Pharmaceutical’s facility in Sola, Ahmedabad.
- Can freshers apply for this Regulatory Affairs Officer role? No, the company specifically requires 1–3 years of relevant experience in regulatory affairs with proven CTD/ACTD dossier preparation exposure.