Work as Senior Regulatory Affairs Assistant at West Coast Pharmaceutical Works Limited

Established in the year 1965. ‘West Coast Pharmaceutical Works Limited’ has garnered a respectable name for itself in the domain of processing, supplying and exporting pharmaceutical products. Over the years, we have grown into a vast organization. Our experience and dedication makes us capable of processing all kinds of effective medicinal products. West-Coast Pharmaceuticals Works Limited is a global pharmaceutical company. It manufactures Pharmaceutical finished formulations, Dietary Supplements & Cosmetic Products. Company also Manufacturer Disinfectant Products. (All hospital disinfectant products), Medicated Soaps, Food Supplements/ Nutraceuticals products, Veterinary products, Sustained release drugs, Ready Premix, Herbal Products, OTC category products.

Post : Senior Regulatory Affairs Assistant

No of posts : 04

Job Description
• Preparation of registration dossiers in CTD/ACTD/Country specific format depending on country requirement.
• Arrangement of registration document as per country requirement.
• Check & approve registration documents prepared by assistant.
• To prepare, check & approve CTD/ACTD/Country specific dossiers as per country guideline.
• To check, verify & approve documents related to dossiers preparation which are received from QC & QA department for dossiers compilation.
• To verify artworks
• To check, verify & approve documents of nonclinical & clinical documents, SPC, PIL, Pack Insert, PSUR for dossier compilation, prepared by assistant
• To check & verify artworks of packaging materials of products for domestic and export market
• Day to day follow-up with various departments for dossier documents requirements
• Filling weekly & monthly work output reports & achievement of targets set by management

Candidate Profile
Candidate have a Regulatory Affairs work experience.

Additional Information
Experience : 4-7 years
Qualification : M.Sc, B.Pharm, M.Pharm
Location : Ahmedabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th March, 2019