Director, Regulatory Affairs (Remote)

Location
Working from Home
Posted
Jun 13, 2022
Ref
4458550004
Required Education
Bachelors Degree
Position Type
Full time

DIRECTOR, REGULAORY AFFAIRS (Remote)

Position Summary:

Reporting to Executive 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:

  • Global Regulatory Leader (GRL), lead the Global Regulatory Team (GRT) and 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 9-14+ 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
  • 4+ years of experience leading teams and/or managing people (i.e., employees, contractors) desired for leadership positions
  • 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.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.