Require Assistant Manager/ Manager- Regulatory Affairs. in Panacea Biotec

Panacea Biotec is a leading research based Health Management Company. 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: Assistant Manager/ Manager- Regulatory Affairs.

Job Description
- Lead & execute the regulatory strategy for Nutraceuticals & Dietary products for India/ROW countries. Obtaining different manufacturing permissions
- Building & maintaining a credible relationship with FSSAI/regulatory authorities
- Providing & review of high quality documents including CMC data, regulatory compliance, electronically transmissible Data as per the agreed timelines
- Dossier preparation & submissions for Dietary/Food supplements and Nutraceuticals in ROW & Domestic markets as per business plan.
- Responsible for sending response to FSSAI/regulatory agencies during product registration timeframes. (Preparation of clear, accessible product labels, PIL's & artworks
- Accountable for the timely preparation and filing of submissions, follow-up and approval of new Marketing Authorizations in line with agreed business plans.
- Preparation of high quality Medical and Scientific communications including patient narratives, literature review, abstracts, product manuals, slide sets presentations for submission to regulatory authorities
- Preparation, Proofreading of Legal applications & Technical Documents before submission to FSSAI at Central & State level.

Additional Information:
Experience: 3-8 Years
Age: 28-35 years
Location: New Delhi
Compensation: As per the Industry
Education: B.Pharma /M.Pharma preferably with Pharmcognosy background
Industry Type: Pharmaceutical or Vaccine
Functional Area: DRA
Last Date: 10^th Oct., 2015