Director at Alloys Consulting Private Limited
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Assistant Manager - International Regulatory Affairs - Pharmaceutical (8-12 yrs)
- 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.
- Preparation of regulatory documents like Declarations, manufacturer authorization for regulatory submission
- Co-ordinate for the sample requirement and dispatch for tender and drug product registration
- Preparation and updation of tracker system for dossier submission, product registration and samples
- Responsible for timely registration of the facility