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Encore Group is a well-established pharmaceutical company with a strong presence in domestic and international markets. Known for its high-quality formulations and regulatory compliance, Encore Group offers a dynamic work environment with opportunities for professional growth.
Job Description – Officer Regulatory Affairs
Key Responsibilities:
- Dossier Preparation: Prepare ACTD/CTD/ECTD dossiers for ROW (Rest of World) markets, ensuring timely and error-free submissions.
- Regulatory Queries: Evaluate and respond to health authority queries and customer requirements efficiently.
- Document Review: Review technical documents like Process Validation, AMV, Stability, and CDP against DMF/Dossier requirements.
- Coordination: Work closely with HO, Plant, ADL, and R&D teams for documents and samples needed for registrations.
- Artwork Checking: Ensure regulatory compliance in artwork development for registration and commercial batches.
- Documentation: Maintain and update regulatory documentation, dossier records, and registration status.
Mandatory Requirement:
- Must have experience in ACTD/CTD/ECTD Dossier Preparation for ROW markets.
How to Apply
Interested candidates meeting the eligibility criteria can send their updated resumes to:
📧 Email: rparab@encoregroup.net
📍 Location: Head Office, Fort – CSMT, Mumbai
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