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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