Are you a dedicated pharma professional with a passion for regulatory compliance? Pharmabharat.org brings you an outstanding career opportunity as a Regulatory Affairs Officer at Encore Group’s head office in Fort, Mumbai. This role in the Regulatory Affairs department offers hands-on experience in dossier preparation, health authority interactions, and maintaining regulatory databases. If you’re seeking a dynamic pharma regulatory affairs job in Mumbai, this position could be your gateway to advancing in the pharmaceutical industry.
Key Responsibilities
As a Regulatory Affairs Officer, you’ll play a crucial role in ensuring compliance and timely submissions for pharmaceutical products. Your duties will include:
- Preparing dossiers in CTD/ACTD/ECTD and country-specific formats for ROW markets, ensuring error-free and timely submissions.
- Evaluating and responding to regulatory queries and customer requirements from health authorities.
- Filing post-approval variations for registered products according to variation guidelines.
- Reviewing technical documents such as process validation, AMV, stability, PDR, and CDP against dossier requirements.
- Coordinating with departments in HO, plant, and R&D for documents and samples needed for dossiers and registrations.
- Developing new artworks and checking them for registration and commercial purposes per regulatory requirements.
- Maintaining and updating regulatory databases for manufacturing, quality documentation, dossier files, registrations, and RLD samples.
- Handling administrative documents like product permissions, COPPs, and FSCs.
Qualifications and Experience
To thrive in this pharma regulatory affairs position, candidates should meet the following criteria:
- Qualification: M. Pharm or B. Pharm.
- Experience: Minimum 2 years in regulatory affairs within the pharmaceutical industry.
- Strong knowledge of regulatory guidelines, dossier preparation, and health authority interactions.
- Excellent coordination skills and attention to detail for reviewing technical documents.
Benefits of Joining Encore Group
This Regulatory Affairs Officer job in Mumbai offers competitive compensation, professional growth opportunities, and exposure to international markets. Enjoy a supportive work environment, skill development programs, and the chance to contribute to innovative pharma products. With a realistic salary range of INR 4-8 lakhs per annum, this role provides stability and career advancement in the thriving pharma sector.
How to Apply
Ready to apply for this exciting pharma regulatory affairs job? Send your resume to rparab@encoregroup.net with the subject line “Application for Regulatory Affairs Officer.” Ensure your application highlights your relevant experience and qualifications. Applications are reviewed on a rolling basis, so apply soon!