SENIOR DIRECTOR, REGULATORY AFFAIRS

The Senior Director, Regulatory Affairs will oversee and direct all global biologics regulatory support and submissions for early to late-stage development and commercial products. Reporting directly to the VP, Global Regulatory Affairs, you will develop regulatory strategies as well as guide strategic direction.

As a key member of the Executive Team, you will work closely with Executive Management in this highly visible position. You will be responsible for establishing regulatory policy and representing the company at external meetings.

Must be comfortable with directing and mentoring the Regulatory Affairs Team with compiling FDA and Ex-US regulatory applications and submissions, INDs, CTAs, BLAs, information and protocol amendments, annual reports, meeting briefing documents, and NDAs.

Qualifications:

• Advanced degree (i.e. M.S., Ph.D., or PharmD) with 10+ years of pharmaceutical and/or biopharmaceutical industry experience
• A minimum of 5 years of senior-level experience in regulatory affairs within the pharmaceutical/biologics industry
• Experience in new product development throughout the product lifecycle, including successful regulatory submission/approval experience
• Demonstrated leadership skills in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people

   

  Please call Cecelia at 240-464-0156 or email at cecelia@morrisexecutivesearch.com