VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS (Remote)
Reporting to the Chief Medical Officer, the Vice President, Global Regulatory Affairs will provide leadership of the Regulatory Affairs function, including strategic and operational oversight of global regulatory activities, with emphasis in the United States, Europe, Middle East, Africa and Latin America.
This individual will lead Regulatory Affairs teams responsible for Clinical Strategy and Regulatory Operations, CMC, Advertising, Promotions and Labelling, and Medical Writing. This position will possess a high level of technical and scientific expertise, a deep understanding of the drug development process, and a thorough understanding of the regulatory environments in the US and Europe.
Responsible for all FDA, EMA, and other health authority interactions, this individual will ensure the highest integrity in regulatory and quality compliance. Critically, this position will partner closely with R&D colleagues to develop, sequence and execute creative, precedent-setting global regulatory strategies for the company’s pipeline and marketed products to maximize probability of regulatory success and ultimately to deliver benefits to an underserved patient population.
Essential Duties and Responsibilities:
- Direct and lead the Regulatory Affairs department strategy to meet company goals globally
- Develop regulatory strategies for the company’s pipeline and in-line products and determine the best regulatory path/action for drug product submissions and regulatory maintenance globally
- Lead all communications and represent the company with FDA, EMA, and other relevant regulatory agencies, including management of preparations for briefing and other documents for regulatory agencies, such as INDs, BLAs, NDAs, and Annual Reports, ensuring adherence to project team timelines and milestones
- Ensure that all non-clinical and clinical programs such as pharmacology, toxicology, and clinical trials are appropriately informed and structured to meet US, European, and other regulatory/compliance requirements
- Build partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through sharing of knowledge, expertise, and relevant information
- Cultivate an atmosphere of collaboration, transparency and problem-solving that encourages requests for advice and input by employees, and create a positive working environment to support the development of Regulatory Affairs team members
- Monitor progress of regulatory projects and responsibilities, including budgets and timelines
- Act as an advisor to facilitate schedules/goals and resolve technical and procedural problems
- Maintain and develop knowledge of regional regulatory requirements that affect clinical development or commercialization needs of company products
- Lead a high-performing Regulatory Affairs team and provide coaching and development to attract, develop and retain top talent
- A Bachelor’s degree in a scientific field. Master’s or advanced (MD, PhD) degree is desirable. At least 9+ years of experience managing people
- Significant and progressive Regulatory Affairs experience (~20 yrs.) in the global biopharma industry, with breadth of responsibility across Regulatory Affairs functional areas
- Track record of innovative and precedent-setting dialogues with regulatory bodies leading to first-cycle approvals. Use of accelerated or breakthrough pathways on medicines to treat conditions for which no drug options existed
- Management of post-IND drug filings through to product approval or label expansion in the US and EU
- Combination of large and small biopharma experience, including leading the scale-up of a Regulatory Affairs department
- Demonstrated leadership and ability to develop and manage a high-performing Regulatory team focused on accountability and meeting and exceeding expectations
- Strong cultural fit with an organization characterized by not only its excellence but its dedication to its mission, its inclusive and respectful culture, and its obligation to ethical responsibility
- Experience managing ex-US and ex-Europe teams or regulatory strategy
- Experience managing Pre-Phase 2 regulatory submissions
- Regulatory Affairs Certification (RAC) is a plus
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
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 may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time 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.