Senior Manager- Regulatory Affairs New Products

Job title: Senior Manager- Regulatory Affairs New Products

Company: Michael Page

Job description:

  • RA management- registration and delivery for new product pipeline
  • Regulatory strategy planning, analysis of risk, procedure management, reporting and delivery of projects

– Provision of support for new product evaluation to BD&L Team

– Preparation of Regulatory submission strategy

-Submitting regulatory applications for new products

-Communicating with the authorities for facilitating the new product submissions

-Responding to regulatory queries, proposing improvement strategies for new products

Opportunity to work with a global Pharma MNCBeing a part of a lean team, growth oriented culture and great compensation

– Candidate must have at least 8 years of RA experience with specific focus on New Product Launches
– Europe market exposure is a must
– Undergraduate degree in a scientific discipline
– Familiarity with NCE Filing, Hybrid submissions required. Centralised procedure experience is a must
– Strong communication skills and presentation skills are a must

A global pharmaMNC

  • Opportunity to work with growth oriented Pharma MNC
  • Manage Regulatory Affairs for new products
  • Be a part of a lean team that gives direct exposure to working with the Executive level
  • Agile working policy

Expected salary:

Location: Mumbai, Maharashtra

Job date: Tue, 11 May 2021 22:43:34 GMT

Apply for the job now!

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