Director/Senior Director, Regulatory Affairs

Director/Senior Director, Regulatory Affairs

About Audentes Therapeutics

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases.  We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown.  Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.

Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.

Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.

The Role

The Director/Senior Director, Regulatory Affairs, reporting to the Senior Vice President, Regulatory Affairs (SVP), is responsible for the development and implementation of global regulatory strategies and associated regulatory submissions for assigned products. The Director/Senior Director, Regulatory Affairs position is a leadership role that will require regular interaction with management from multiple internal functional areas, strategic partners, international regulators and external experts in a fast paced and dynamic environment. This position will be based in our San Francisco headquarters.

The specific responsibilities of this position include:

  • Develop and implement global regulatory strategy and contingencies for assigned projects in partnership with SVP
  • Prepare, review and submit relevant regulatory documents to the appropriate regulatory authorities for assigned projects
  • Serve as the primary interface for FDA and global competent health authorities on assigned projects
  • Work with functional areas and strategic partner working groups to define contributions to regulatory submissions
  • Lead regulatory submission teams for assigned projects
  • Provide project plans and timelines in coordination with Program Management for regulatory submissions (and other) activities
  • Prepare project/study team for FDA and other regulatory health agency meetings, as required
  • Maintain knowledge of regulatory environment, regulations and guidance
  • Contribute to the development and maintenance of regulatory affairs working practices and procedures
  • Support due diligence efforts

Required Education, Skills and Experience

  • BS, MS or PhD in a scientific discipline with 12+ years' biotech or pharmaceutical Regulatory Affairs experience and 3+ years' experience managing
  • Advanced knowledge and experience in understanding and interpretation of regulations and guidelines related to all phases of drug development
  • Desire and proven ability to work in a fast-paced, start-up environment
  • Outstanding collaboration, problem solving team player with excellent written and oral communication and organizational skills
  • Strong attention to detail, excellent organizational skills and history of success leading and working on multiples projects with tight deadlines
  • Strong computer skills including MS Office (Word, Excel, Outlook, PowerPoint, Project)
  • Commitment to Audentes values: Be BOLD, Care deeply, #GSD

Preferred Education, Skills and Experience

  • Rare disease and/or cell or gene therapy experience
  • Experience supervising and mentoring associate or manager level Regulatory staff

Job Details

Reference # 2019B-209
Posted on 20 Mar 2019
Closes on
Location(s) San Francisco
Department Regulatory
Career level Management
Hours/Status Full-time
More details (document)
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