Career Opportunities
Senior Director - Head of Global Regulatory Affairs
Sep 6, 2016
New Jersey
Pay: TBD

 

  The Senior Director, Head of Global Regulatory Affairs leads the regulatory function. This individual is responsible for directing all regulatory activities from preclinical development through filing of marketing applications and post-approval activities. The Senior Director leads the efforts to obtain worldwide approvals to market products and provides ongoing regulatory support for commercial products. This individual is responsible for professional development of department members.

Responsibilities:
• Develops and implements strategic regulatory plans for clinical manufacturing and preclinical programs.
• Ensures compliance with FDA/ICH regulations and guidelines related to preclinical and clinical, regulatory submissions, product launch, labeling, and promotional activities.
• Directs regulatory activities pertaining to Health Authority meetings and negotiations.
• Works closely with development teams, by providing guidance and technical input.
• Provides regulatory support to the business development activities to review potential licensing candidates.
• Reviews responses to inquires from regulatory agencies.
• Responsible for identifying and maintaining a network of external regulatory consultants to assist internal staff with meeting regulatory goals and timelines.
• Develops and implements strategies for the most efficient regulatory filings.
• Responsible for all aspects of US, EU and rest-of-world regulatory filings and post-approval regulatory activities.
• Oversees the approval of materials used by the sales force, scientific staff and medical liaisons for compliance with FDA regulations.
• Undertakes ongoing performance review, feedback and development of staff.

Qualifications: 
• Bachelor’s degree in scientific or life sciences discipline or related field required. 
• Advanced degree in scientific or life sciences discipline or related field (e.g., PharmD, PhD, MD) strongly preferred.
• A minimum of 12-15+ years of progressive leadership in regulatory affairs in the biotech/pharmaceutical industry is required. 
• Direct responsibility for one or more original NDA filing(s) in the US preferred. 
• Strong understanding of US and international pharmaceutical guidelines and regulations is required experience in establishing and delivering on European and other international regulatory strategies strongly preferred.
• Experience and/or knowledge of biologics, cell therapies, small molecules preferred. 
• Expert knowledge of FDA and EMEA.
• Ability to build and foster strong relationships.
• Decisive and proactive with hands-on, can-do style and attitude and the ability to prioritize are critical for success.
• Exceptional analytical skills.
• Ability to see the big picture while ensuring the quality of detail.
• Ability to serve on multiple interdepartmental teams and to act as team leader.
• Must demonstrate a keen attention to detail.
• Excellent writing, communication, presentation, skills.
• Demonstrated leadership and project management skills.
• Strong interpersonal and tactful negotiation skills. 
• Proven ability to work on multiple projects in a fast paced environment.
CANDIDATE MUST HAVE VERIFICATION
  1. Bachelor degree
  2. Direct interaction with FDA
  3. Global Regulatory Affairs Strategy for Clinical Development
  4. Biologics or Cell Therapies
  5. Hands-on, Leadership Gravitas