Regulatory Affairs

2 days ago

India Sunrise Remedies Full time

Sunrise Remedies Job Opening for Regulatory Affairs (RA).

**Experience**: Minimum 2 Years
**Industries**: Pharmaceutical Company
**Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm
**Job Location**: Santej Ahmedabad.

**Key Responsibilities**:

- Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. Should know Dossier Preparation.
- Dossier preparation/review as per country specific guideline/CTD guideline
- Timely query response submission to Distributor/ MOH
- Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement)
- Preparation, review & release of artworks & sales order as per country approval
- Variation documents preparation and filing as per country requirements
- Should be able to review & interpret the requirement as per country specific/ tender guideline
- Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master file, BMR, APR etc.

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