Shepherd Regulatory Search has 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 integral role, you will be responsible for leading the development of global regulatory strategies for the TA.

Organization: Our client is among the global leading biotherapeutics organizations, with a presence in over 55+ countries, 18K+ employees and a rapidly growing pipeline. They have an unparalleled passion and commitment to save and improve lives across the globe, now is an exciting time to join this team.

Responsibilities:

• Provide scientific and regulatory vision and leadership in developing global regulatory strategies for this firm’s developmental portfolio.
• Work alongside key project management, clinical development and commercial development leads to ensure successful development of global regulatory strategies.
• Accountable for all clinical/ safety related submissions and communication with the FDA, EMA and other Regulatory Agencies.
• Participate in health authority meetings when needed.

Knowledge and Skills:

• A minimum of 15 years’ experience in biotech or pharmaceutical industries with at least 10 years in Regulatory Affairs.
• 7 years’ experience (minimum) in leading and managing teams and promoting an engaging collaborative team environment.
• Solid background working in a complex and matrix setting required.
• Experience working in Regulatory Affairs across 2+ 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