Opening to work as as DRA - Executive / Sr.Executive at Panacea Biotec - Exp candidates
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: Regulatory Affairs - Executive/ Sr. Executive
-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
-Review of respective Products File/Dossiers/PDR/Cell bank dossier/ stability data and specifications
-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
-Giving Regulatory inputs as per the updated guidelines
-Preparation of PSF (Product Summary File) for WHO PQ.
-Exposure in filling dossiers in VACCINES.
Experience: 2-4 years
Age: 25-27 Years
Location: New Delhi, Corporate Office
Education: B.Pharma, M.Pharma/ M.Sc
Industry Type: Pharmaceutical & Vaccine
Functional Area: Regulatory Affairs - Biologicals
Compensation: As per industry norm
Last Date: 23rd February, 2016
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