Director, Regulatory Affairs

Responsibilities

• Lead regulatory activities for filing INDs, CTAs, and maintenance activities for open applications, including DSURs, IND/CTA amendments, and responses to requests for information/queries.
• Work effectively and collaboratively with internal and external stakeholders to manage clinical regulatory activities, including study start-up, management of CRO counterparts, completion of initial application submissions & amendments, obtain approvals from regulatory authorities, while ensuring global regulatory compliance standards and commitments are met.
• Strategically partner with senior regulatory management, development teams, and health authorities to maximize potential for each product in development.
• Provide regulatory guidance, including identifying and assessing regulatory risk.
• Ensure that regulatory documents are accurate, complete, and verifiable, and confirm compliance with regulatory requirements.
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.
• Proactively review and interpret health authority feedback, regulatory precedent, guidelines, and policy to drive product strategy and to guide decision making within cross-functional teams.
• Work collaboratively with regulatory operations team to provide oversight of relevant regulatory submissions and optimize submission processes.
• Assist with the management of applicable health authority interactions – planning, briefing material development, and meeting preparation leadership.
• Provide regulatory representation and expertise on cross-functional project teams and sub-teams/study management teams.
• Regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, statistical analysis plans, investigator’s brochures, and clinical study reports.
• Review essential documents for regulatory green light for opening new clinical trial sites and sign off on IP shipments.
• Establish departmental processes, policies, guidelines, and SOPs.
• Ensure compliance with all applicable domestic and international regulations.
• Develop team members, set clear goals, delegate effectively, and monitor performance to ensure the team operates efficiently.
• Conduct regular 1:1s and deliver timely, actionable feedback; write and deliver meaningful performance reviews for all direct reports.
• Foster open communication and a motivating team environment, inspiring members to do their best work.

Qualifications

• BS/MS/PhD in a life science with at least 10 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry; PhD degree may offset some experience requirements.
• Experience with cell therapy/CAR T/gene therapy products preferred.
• Demonstrated direct experience with Health Authority submissions and strong knowledge of FDA/EMA/MHRA regulations and agency submission and approval processes.
• Proven experience in applying regulatory knowledge to various clinical activities; strong knowledge of clinical study design, Good Clinical Practice principles, and navigation of clinical development pathways for novel products.
• Experience in creating the process for management of the preparation of annual reports, DSURs, and Investigator’s Brochures.
• Strong knowledge of the regulatory requirements for a variety of clinical regulatory documents (protocols, ICFs, CSRs, etc.).
• In-depth knowledge of various clinical areas (clinical development, clinical operations, safety, etc.)
• Strong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly.
• Excellent operational skills including planning, organizing, and the ability to deal effectively with a variety of personnel both internally and outside the company to drive projects to timely completion.
• Excellent writing, communication, and interpretive skills.
• High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently.
• Veeva Vault RIM experience preferred.
• Prior direct interaction with Health Authorities is desirable.
• RAC preferred.

Working conditions & physical requirements

• Travel may be required (up to 10%)​
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. ​

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated salary range for this role is $220,000 - $245,000.