Sunrise Remedies Job Opening for Regulatory Affairs (RA) officer.
Experience: 1 Year
Industries: Pharmaceutical Company
Education: B.Sc. | M.Sc | B.Pharm | M.Pharm
Job Location: Santej Ahmedabad.
Facilities Provided:
– Transportation Facility Available (As Per Circumference Of Sunrise Remedies)*
– Mediclaim and Food Facility provide By Company.*
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.
Please drop your CV or Resume to [email protected]
Our HR Department will get in touch with you.