Director, Regulatory Affairs

Location
San Francisco, CA, United States
Posted
Mar 12, 2021
Ref
793
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
DIRECTOR, CLINICAL REGULAORY AFFAIRS

Position Summary:

Reporting to Senior Director, Regulatory Affairs, the Director will provide leadership, and drive successful completion on all regulatory activities of assigned projects. These include providing strategic input on global regulatory strategies for pipeline products and/or life cycle management of marketed products, as well as operational leadership in the preparation and compilation of regulatory submissions, managing regulatory submission processes and timelines, and collaborating with Regulatory Operations to ensure timely submissions. The candidate will serve as the primary contact with the FDA and other health authorities, and may manage the activities of other Regulatory Affairs staff, consultants and/or contractors in the performance of the duties outlined below.

Essential Duties and Responsibilities:

  • Serve as the Regulatory Affairs representative on assigned product teams
  • Provide strategic guidance to multidisciplinary teams on the regulatory requirements to support all stages of clinical development of small molecules and/or biologics, including timely development and execution of robust global regulatory strategies and plans
  • Maintain an understanding and awareness of existing and emerging legislation and guidelines that may affect GBT programs
  • Develop regulatory strategic plans in collaboration with project teams. Collaborate with team members to ensure agreed timelines and milestones are met
  • Responsible for clinical and nonclinical components of IND/CTA/NDA/BLA/MAA submissions. Set strategy for submissions of product registration documents to health authorities. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions
  • Provide interpretation of regulatory health authorities' feedback, policies and guidelines to GBT personnel. Serve as the liaison between GBT and regulatory authorities for assigned products
  • Utilize regulatory expertise and knowledge and collaborate with project teams to resolve complex issues and develop options that maximize likelihood of regulatory success, including approval of marketing applications
  • Effectively plan, organize, and conduct, in close collaboration with cross-functional team members, formal meetings with health authorities
  • Provide organizational support and be prepared to manage direct reports/consultants as the company grows


Qualifications:

  • Bachelor's degree in a Life Sciences discipline or equivalent, advanced degree preferred
  • Minimum 12 years of pharmaceutical/biopharmaceutical experience of which at least 10 years of experience in Regulatory Affairs and successful IND and NDA/BLA/MAA submission experience
  • Experience with both small molecules and biologics
  • Experience with pediatric development is a plus
  • Balance of strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills
  • Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule / biologics guidelines and regulations is a plus
  • Demonstrated excellence in regulatory liaison/strategy
  • Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams
  • Excellent organizational, interpersonal, and communication skills with the ability to build relationships at all levels of the organization


Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.