Jubilant Pharma Limited Looking For Director/Associate Director-Regulatory Affairs at Noida, Uttar Pradesh, Full Time

Job Context:

This role will focus on New Drug Application & Biologics Applications. Ensures execution and submission of documents, responses and filing of NDAs and BLAs to US FDA. Also prepares plans and conducts meetings with regulatory agencies. Supervision of preparation of regulatory documents and response to regulatory agencies including preparation and review of scientific technical documents for regulatory adequacy and compliance

Education.

Ph.D./ Master’s in Chemistry, Biochemistry, Regulatory Affairs, Pharmaceuticals, Biology with relevant experience in the pharmaceutical industry required.

Experience Range.

Minimum of 12+ years in Regulatory Affairs and in Pharmaceutical industry specifically focused on US FDA submission for NDA and BLA Environment.

Accountabilities.

Defines the Regulatory Strategy for all products that require NDA and BLA submissions from the Radiopharmaceuticals Division, including Nuclear Medicine Imaging Tracers, nuclear medicine therapeutic pharmaceuticals.

Supports business development activities with feasibility studies and regulatory pathway analyses for potential new products.

Provides Regulatory expertise to other departments (R&D, Manufacturing, QA, QC and Marketing) also provides support on labeling and advertising issue related with NDA.

Ensure compliance with government regulations by providing agencies with all necessary pharmaceutical and technical information relating to changes or modifications of the company’s products.

Manages day-to-day Regulatory affairs operations including budget management and preparation. Performs additional duties as assigned by Management.

Key Interfaces.

Regulatory Agencies, Key Opinion Leaders, Consultants. KOL, Quality, Marketing, Sales, R&D, Legal, Finance.