Regulatory Affairs Executive - Manager (Ahmedabad)

Regulatory Affairs Executive - Manager (Ahmedabad)

Roles and Responsibilities:-

Collect and coordinate information and compile regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy.
Preparation & compilation of dossier in CTD, ACTD, ECTD & country specific format according to guidelines of countries.
Response to query/deficiency/Notice of Deficiency raised by Drug Regulatory Authority or technical representative.
Coordination with Quality Control, Quality Assurance and Production department for regulatory documents.
Timely compile documents for license renewals, update and re-registrations.
Maintain regulatory files/database and chronologies in good order.
Establish and maintain system for tracking drug product registration, samples submitted to agencies or partners.
Compilation of Technical Dossier for Tender participation.
Review changes to existing products and SOPs to define the requirements for regulatory submissions.
Review of technical documents like BMR, Stability protocol & report,



specification and method of analysis, process validation protocol and report required for dossier compilation.
Initiation and review of drug product artworks like Package Insert, Summary of Product characteristics (SmPC), label, foil and carton for compliance with regulatory requirements.
Must Have dossier submission exposure in ROW and EU market.
Valuable exposure of Team handling & day to day report
Sound knowledge of ICH and country specific guidelines
Excellent skill in Deficiency response preparation.
Excellent knowledge of Technical documents review.
Other activities assign by RA Head.
Must have experience in Parenterals Product

Note:- Only local candidate highly preferable.

Do not apply freshers.

Education:
B.pharm / M.pharm

Experience:
2Years to 10 Years

Location :
Sindhu Bhavan, Ahmedabad

e-mail :
[email protected]

Website
www.swiss.in

📌 Regulatory Affairs Executive - Manager (Ahmedabad)
🏢 Swiss Parenterals
📍 Ahmedabad