West-Coast Pharmaceutical Works Ltd., a leading name in the Indian pharmaceutical industry, is urgently hiring a Regulatory Affairs Officer for its headquarters in Sola, Ahmedabad, Gujarat. This is an excellent full-time opportunity for B.Pharm or M.Pharm graduates with 1–3 years of hands-on experience in regulatory affairs, especially in CTD/ACTD dossier preparation and documentation for regulated markets (ROW & EU). If you are searching for regulatory affairs jobs in Ahmedabad or pharma regulatory affairs officer vacancies in Gujarat, this role offers stability and growth in a reputed organization.
Key Responsibilities
- Prepare and review CTD and ACTD dossiers for domestic and international submissions
- Handle FDA documentation including Product Permission (PP), COPP, GMP certificates, etc.
- 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 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: ✉️ hrdho@westcoastin.com 📞 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 – Pharmabharat” in the subject line for faster processing.
Frequently Asked Questions (FAQs)
1. 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.
2. 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.
