Vice President, Regulatory Affairs

San Francisco, CA, United States
Dec 02, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Position Summary:

The Vice President, Regulatory Affairs will provide leadership of the Regulatory Affairs function. This includes strategic and operational oversight of all US and ROW regulatory activities, as well as, management of the personnel/contractors in the Regulatory Affairs Department. The candidate will serve as an internal subject matter expert with respect to the interpretation of drug development regulations and guidance and will be the primary point-of-contact for external consultants to inform the Company's regulatory strategy. This person will oversee all FDA and other regulatory interaction for the Company's product candidates while ensuring the highest integrity in regulatory and quality compliance.

Essential Duties and Responsibilities:
  • Utilize regulatory expertise and knowledge of regulatory requirements and regulations to develop regulatory strategic plans for cross-functional project teams
  • Provide counsel, training, and interpretation of FDA and other regulatory authority feedback, policies and guidelines to GBT personnel
  • Assist in the design of Clinical Studies required for Regulatory Approvals
  • Sets strategy for submissions of product registration documents to health authorities worldwide
  • Accountable for filing of IND/CTA/NDA/MAA submissions by ensuring adherence to project team timelines and milestones
  • Interacts with other functions in the preparation, review, and completion of documents for regulatory submissions
  • Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies
  • Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications
  • Provide Regulatory Compliance consultation related to Promotional and Scientific Exchange content and activities in preparation for product commercialization
  • Manage, mentor, and develop a team of personnel in Regulatory Affairs & Operations

  • Bachelor's degree in a Life Sciences discipline or equivalent, advanced degree preferred
  • Minimum of 15 years of biopharmaceutical experience, of which at least 12 years include hands-on Regulatory Affairs experience with seven (7) years of progressive leadership experience
  • Balance of strategic thinking and strong analytical skills with ability to execute
  • Detail oriented and results driven with strong written, verbal communication and presentation skills
  • Track record of successful product approvals in the US and EU
  • Experience in CMC Regulatory preferred
  • Working knowledge of the Regulatory Operations function and submission logistics
  • Knowledge in cGMP and other Regulatory (CMC, preclinical) compliance requirements
  • Possess a broad knowledge of biopharmaceutical manufacturing and operations
  • Experience with international regulatory submissions and an understanding of worldwide small molecule guidelines and regulations preferred
  • Proven ability to develop and manage a high performance regulatory team focused on accountability and meeting and exceeding expectations

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.