Director at Alloys Consulting Private Limited
Views:115 Applications:5 Rec. Actions:Recruiter Actions:2
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
This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.