Are you a B.Pharma or M.Pharma graduate looking to kickstart or advance your career in the pharmaceutical industry? Encore Healthcare Pvt. Ltd., a renowned name in the healthcare sector, is hiring for the positions of Officer Regulatory Affairs and Trainee – Regulatory Affairs at their Head Office in Fort – CSMT, Mumbai. This is an excellent opportunity to join a dynamic team and contribute to the global pharmaceutical market.
About Encore Healthcare Pvt. Ltd.
Encore Healthcare Pvt. Ltd. is a leading player in the pharmaceutical industry, known for its commitment to quality and innovation. With a strong presence in both domestic and international markets, the company specializes in the development, manufacturing, and marketing of a wide range of pharmaceutical products. Their Regulatory Affairs department plays a pivotal role in ensuring compliance with global regulatory standards and facilitating seamless market access.
Job Details
- Designation: Officer Regulatory Affairs & Trainee – RA
- Location: Head Office, Fort – CSMT, Mumbai
- Department: Regulatory Affairs
- Education: B.Pharma / M.Pharma
- Working Days: 5 Days a Week (Monday to Friday)
- Weekly Off: Saturday & Sunday
- Website:Â Encore Healthcare Pvt. Ltd.
Key Responsibilities
As part of the Regulatory Affairs team, you will be responsible for:
- Dossier Preparation: Preparing ACTD/CTD/ECTD dossiers for the ROW (Rest of the World) market, ensuring error-free and timely submissions as per the marketing department’s timeline.
- Regulatory Queries: Evaluating and responding to regulatory queries from health authorities or customers to ensure compliance and satisfaction.
- Document Review: Reviewing technical documents such as process validation, AMV, stability data, and CDP received from Site QA or R&D/ADL against DMF/dossier requirements.
- Coordination: Collaborating with various departments (HO, Plant, ADL, R&D) to gather necessary documents and samples for dossier preparation and registration purposes.
- Artwork Development: Checking and developing artwork for registration and commercial purposes as per regulatory requirements.
- Documentation: Maintaining and updating all documentation, dossier records, and registration statuses.
Why Join Encore Healthcare?
- 5-Day Workweek: Enjoy a healthy work-life balance with weekends off.
- Learning Opportunities: Gain hands-on experience in regulatory affairs and dossier preparation for global markets.
- Career Growth: Be part of a growing organization with ample opportunities for professional development.
- Team Environment: Work with a supportive and collaborative team in a state-of-the-art facility.
How to Apply
If you meet the eligibility criteria and are excited about this opportunity, send your updated resume to Rashmi Parab, Manager Group HR, at rparab@encoregroup.net.
