Swiss Parenterals Ltd - Openings for Officer / Executive / Sr. Executive - Regulatory Affairs
RA Officer / Executive / Sr. Executive @ Swiss Parenterals Ltd
Job description:
· 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 ACTD, CTD & country specific format according to guidelines of various 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.
Candidate profile:
Having experience in latam and CIS regions
Will be reporting to Director.
Experience: 1-6 yrs
Qualification: B.Pharm / M.Pharm
Contact Person: Anita Bhatt
Contact E Mail ID: hr@swiss.in
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