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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
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.
- 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.
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