Regulatory Affairs Professional
4 weeks ago
The role of the Assistant Manager of Regulatory Affairs at Ashish Life Science Pvt. Ltd. is to ensure that products meet all regulatory requirements for approval and market entry, maintain documentation, and coordinate with various departments to ensure timely submissions.
This position involves monitoring regulatory changes, preparing dossiers, and communicating with regulatory bodies.
Key Responsibilities:- Regulatory Submissions:
- Prepare, compile, and review regulatory submissions, including ANDAs (Abbreviated New Drug Applications), NDAs (New Drug Applications), CTDs (Common Technical Documents), and other dossiers required for product approval.
- Evaluate and ensure the completeness of submission packages.
- Collaborate with R&D, Quality Assurance, and Manufacturing teams to gather necessary documentation for submissions.
- Regulatory Compliance:
- Evaluate and approve product labeling, packaging, and promotional materials for compliance with regulatory standards.
- Maintain up-to-date knowledge of current and changing regulations in key markets.
- Documentation and Record Keeping:
- Maintain accurate and comprehensive regulatory documentation, including product master files, technical files, and registration certificates.
- Update and manage regulatory databases to track submission statuses, approvals, and regulatory commitments.
- Regulatory Strategy:
- Assist in developing regulatory strategies to support the timely approval and market launch of products.
- Provide input on regulatory pathways for new products and lifecycle management of existing products.
- Identify potential regulatory risks and provide mitigation strategies.
- Communication and Liaison:
- Serve as a point of contact between the company and regulatory agencies.
- Respond to queries and requests from regulatory bodies in a timely and accurate manner.
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