Associate Director, Regulatory Affairs

Location
San Francisco, CA, United States
Posted
Oct 02, 2020
Ref
793
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
ASSOCIATE DIRECTOR, REGULATORY AFFAIRS

Position Summary:

Reporting to Senior Director, Regulatory Affairs, the Associate Director will support day-to-day 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, leading preparation and compilation of regulatory submissions, managing regulatory submission processes and timelines, and collaborating with Regulatory Operations to ensure timely submissions. The candidate may 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:
  • 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
  • Lead multidisciplinary teams in the authoring of regulatory documents, including scientific advice briefing packages, INDs/CTAs, NDAs/BLAs/MAAs, and supplements/variations
  • Oversee and ensure compliance with regulatory procedures and work practices; support processes by which regulatory submissions are reviewed, finalized, and signed-off
  • Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks
  • Assure compliance with project team timelines and milestones
  • Manage and track queries from and commitments to health authorities, collaborate with subject matter experts to provide written responses to queries, and provide periodic status updates regarding unfulfilled conditions/commitments
  • Train and mentor regulatory personnel on strategic matters related to company and external information
  • Maintain an understanding and awareness of existing and emerging legislation and guidelines that may affect GBT programs


Qualifications:
  • Bachelor's degree in a Life Sciences discipline or equivalent, advanced degree preferred
  • Minimum of 5-8 years of experience in Regulatory Affairs
  • Strong knowledge of FDA/ICH and foreign regulations and guidelines for the development of small molecule and biologic products
  • Excellent organizational, interpersonal, and communication skills with the ability to build relationships at all levels of the organization
  • Ability to work independently on multiple projects with tight timelines and minimal supervision
  • Experience working in cross-functional, global, virtual teams
  • Demonstrated regulatory experience in coordinating the preparation of US and international regulatory submissions
  • Experience in eCTD format and structure
  • Balance of strategic thinking and strong analytical skills with ability to execute
  • High attention to detail; ability to organize, prioritize, and delegate assigned projects

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.