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Executive Director, Regulatory Affairs, Clinical and Nonclinical

Location San Rafael, California

Director, Regulatory Affairs, Clinical and Nonclinical

SUMMARY

This position will direct the clinical and nonclinical regulatory strategy for multiple products for rare diseases that represent serious, unmet medical conditions. The position will serve as the Global Regulatory Lead (GRL) for a biological product currently in clinical trials for a rare neurological disease and may oversee additional development programs. The position will lead the Global Regulatory Team and, working with the regional regulatory team members, will develop the global regulatory strategy and oversee its execution. The Director will serve as the regulatory affairs representative on the corporate product core team and as the primary liaison for the US FDA. Candidates must have proven expertise in working collaboratively and driving for results in a team setting as well as demonstrated skills in communicating with internal and external stakeholders.

RESPONSIBILITIES

  • Lead interdisciplinary regulatory team in establishing global regulatory strategy for late-stage development programs
  • Oversee planning, preparation, and submission of clinical trial applications and marketing applications in the US and internationally
  • Provide strategic regulatory insight to the project team regarding product development
  • Lead interactions with regulatory health authorities
  • Manage and mentor multiple manager-level and associate-level direct reports
  • Communicate with regulatory consultants regarding product development plans
  • Interact with executive leadership team to discuss global regulatory plans

EDUCATION

  • MD, PharmD, or PhD, preferably in a science related to medicine and minimum of 6 years of experiencein Regulatory Affairs in the biotechnology or pharmaceutical industry with a clinical and nonclinical emphasis,or
  • MS degree with 8+ years of experience described above, or
  • BS degree with 10+ years of experience described above

EXPERIENCE

Required

  • Minimum of 4 years of experience in managing regulatory staff
  • Skilled at gathering supportive information and developing product approval strategies
  • Demonstrated leadership in defining novel approaches to product development and approval
  • Proven track record of managing critical projects as a part of aninterdisciplinary team
  • History of achieving regulatory goals in ambiguous and sometimes challenging situations
  • Proven track record of successfully interacting and negotiating with regulatory health authorities
  • Prior experience leading cross-functional teams in the coordination of regulatory submissionsand successfully managing projects to deadlines
  • Thorough understanding of global regulatory environmentand relevant drug development regulations and guidelines
  • Outstanding interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities
  • History of solving regulatory problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Preferred

  • Rare disease experience is desirable
  • Prior experience with both biologics and small molecules is desirable

US and international experience preferred

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San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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