full time legal management senior

Job Details

Senior Director OR Director, Global Regulatory Strategy

Lexington, MA

Summary:

Actively looking to grow the Regulatory team, my client is seeking to add a very qualified Director or Senior Director Global Regulatory Strategy candidate to the team! The company is looking for a highly motivated individual who will be responsible for developing and implementing global Regulatory strategy, taking the lead on one or more products in the robust pipeline, while ensuring successful registration and life-cycle management. If you are looking for a new opportunity with a fast pace, growing biopharmaceutical company, please apply!

RESPONSIBILITIES

In this role you will be responsible for:

  • Define, develop, and lead all global Regulatory strategies
  • Provide Regulatory Strategic leadership for Drug Development projects, health authority interactions, submissions, etc
  • Lead the Regulatory department, while working cross-functionally amongst all other teams regional counterparts
  • Prepare all... documents submitted to FDA/EMA and other Health Authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, IMPDs, PIPs, amendments, safety reports, and annual updates
  • Act as the direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports of junior staff as needed.
  • Provide leadership and development for direct reports and for those that serve as global regulatory leads responsible for the design and execution of GRA strategies

REQUIREMENTS

In this role you will be required to have:

  • 10-15 years of pharmaceutical industry experience
  • At least 10 years of Regulatory experience
  • Prior experience with FDA and EMA, and success with filing BLAs/NDAs/MAAs. Experience with both early and late stage drug development
  • Solid working knowledge of drug development process and regulatory requirements (i.e understanding of broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies)
  • Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability

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