Desired Profile Lead and execute the regulatory strategy for biological products for ROW countries.
Dossier preparation & submissions for biological product in ROW countries as per business plan.
Responsible for Regulatory Affairs of vaccines, bio-therapeutics, enzymes & antibiotics.
Responsible for Registration filing with DCGI & WHO and would be involved in new product registrations.
Dealing with Clinical Trial submissions and post approval changes.
Preparation of application on Form 8, 9, 12, 40, 44, 27-D, Wholesale Licenses and renewal of licenses wherever applicable.
Preparation of application for grant of GMP/COPP/FSC/Non-Conviction Certificate, Capacity Certificate, Technical Staff Approvals and renewal of licenses wherever applicable
Preparation of documents for attestation from SDCA(State Drug Control Authority ) for the Tender purpose
Preparation and compilation of dossier for RCGM submission for obtaining NOC from chemical trials & CITES NOC from DGFT.
Follow ups with licensing authorities & submitting the response to their queries raised by regulatory authorities.
Preparation of Product Summary File (PSF) for WHO PQ.
Ensuring that company’s products comply with the regulations of the respective Regulatory Agency.
Keeping abreast of ROW legislation, guidelines and customer practices in all countries that the company is exporting.
Monitoring and setting timelines for license variations and renewal approvals.
Advising scientists and manufacturers on regulatory requirements.
Providing strategic regulatory advice to senior management throughout the development of a new product.
Documents review - CMC data, Process validation, AMV, Specifications, STP, DMF, Clinical & non clinical data, Stability reports & SMF according to country specific requirements.
Co-ordination with QA for plant inspection by NRA of respective country.
Handling of issues like Changes, complaints, regulatory compliances, notifications, Post registration activities & variation filing.
Handling of ADR’s, Submission of PSUR’s, Arrangement of Licenses, RLD & upkeep of the records.
Responsible for Change control, Risk Assessment, control management system, handling the inspections and CAPA preparation
Experience 4-8 years
Age up to 35 years
Industry Type Biotechnology
Functional Area Regulatory Affairs ( Biologicals)
Compensation As per industry norm
Location New Delhi
Contact 011-41679000 (Extn.2022)