Manager Regulatory Affairs Jobs 2021 | Novartis Careers April 2021

Job Title: Senior Manager Regulatory Affairs

Location: Pakistan
Terms: Full-Time
Manager Regulatory Affairs Jobs 2021 | Novartis Careers April 2021

About Company (Novartis Pharma (Pakistan) Ltd):

Our mission is to discover new ways to improve and extend people’s lives.

Our global portfolio of innovative patented medicines includes more than 50 key marketed products, many of which are among the leaders in their therapeutic areas.

Sandoz Division is a global leader in generic medicines and biosimilars, offering more than 1,000 different types of high-quality, affordable products across a broad range of therapeutic areas. It pioneers new ways to help people around the world access high-quality medicines.

Manager Regulatory Affairs Jobs 2021 | Novartis Careers April 2021

Job Responsibilities:

  • -responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.
  • -Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions. -Partners with regions to align on regulatory strategy in order to fulfil business objectives.
  • -Implement RFP across assigned regions.
  • -Determine requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
  • -Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.

Requirements :

  • Regulatory process understanding in Pakistan. Proven track record of successful filing and approval of Drugs.

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