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.
Interested candidates can send their updated resumes to [email protected]