Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.
Post : Sr. Executive/Assistant Manager-RA (Biologicals)
Job Description
- 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
Additional Information
Experience : 4-8 years
Age : up to 35 years
Industry Type : Biotechnology
Functional Area : Regulatory Affairs ( Biologicals)
Education : M.Sc.(Biotechnology/Microbiology)
Location : New Delhi
Share your CV at : singhjyoti@panaceabiotec.com
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