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Company Contact Info

  • King of Prussia, PA
  • Ed Canning

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Senior Director, Regulatory Therapeutic Area Lead

Shepherd Search Group • King of Prussia, PA

Posted 1 month ago

Job Snapshot

Full-Time
Experience - 99 years
Degree - 4 Year Degree
Pharmaceutical, Healthcare - Health Services
Health Care, Pharmaceutical

Job Description

We have a newly created opportunity for a Senior Director Therapeutic Area Lead that will oversee a global team of GRLs and will be one of five decision makers on the R&D-wide TA leadership team.

 

In this highly visible role, you will be responsible for leading the development of global regulatory strategies for the TA.

 

Organization: My client is an established, world-class biotherapeutics organization, with a presence in over 60 countries, 20k+ employees and an expanding pipeline. With a passion and commitment to delivering on their promise to save and improve lives across the globe, now is an exciting time to join this team.

 

Responsibilities:

  • Provide forward-thinking scientific and regulatory vision, leadership, and oversight, in creating global regulatory strategies for the developmental portfolio.
  • Collaborate with key project management, clinical development and commercial development leads to ensure successful development of and execution of global regulatory strategies.
  • Responsible for all clinical/ safety related submissions and interaction with the FDA, EMA and other Regulatory Agencies.
  • Participate in health authority meetings when needed.

Job Requirements

Knowledge and Skills:

 

  • At least 15 years' experience in the biotech or pharmaceutical industries with a minimum of 10 years’ experience in Regulatory Affairs required.
  • A minimum of 7 years of experience in managing teams within a collaborative team environment required.
  • Experience working in a complex and matrix setting required.
  • Experience working in Regulatory Affairs across two or more geographic areas (preferably the US and EU)
  •  A sound knowledge and understanding of pharmaceutical / biological product development and regulatory conditions for product development and approval in more than one key region (US, EU, Japan) 


Contact: Ed Canning

Shepherd Search Group® is an executive search & recruitment firm providing leaders for a growing umbrella of industries, including: Regulatory Affairs, Engineering, Construction, Manufacturing, Finance & Tax, telecommunications and optics, PV and nanotechnology. . We have three distinct service lines: Executive Search & Recruitment, Interim Staffing and RPO (Recruitment Process Outsourcing). We have placed the very best industry talent at regional and national corporations for almost 30 years.

To learn more about Shepherd Search Group: Click Here

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