Assistant Manager - International Regulatory Affairs - Pharma

Job Description

Roles & 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 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

- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products

- Actively participate in evaluation of regulatory compliance of document /product/ process/test methods changes

- Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.

- Product Permit

- Food & Drug Related work

- COPP

- Renewal of licence

- WHO GMP work with CDSCO

- Product Permission