Sr Manager / Associate Director of Regulatory Affairs US Lead

Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next-generation biologics from concept to clinic.

Summary

Fortvita is seeking a dynamic and experienced Sr Manager / Associate Director of Regulatory Affairs. The role is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). Provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio. Leads and coordinates local project team members in developing strategy for applicable documents / activities. This role is hybrid and located in Palo Alto, CA.

Responsibilities

• Primarily function as a US-Regulatory Leader and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL).
• Provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio.
• Depending on the candidate’s skill set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stage.
• Leads and coordinates local project team members in developing strategy for applicable documents / activities.
• Ensures quality and content of submissions to Health Authorities.
• Depending on skill set and as deemed appropriate by the GRL, may lead regional Health Authority meetings and liaison with local Health Authority and company governance boards for assigned projects.
• Depending on the skill set and as deemed appropriate by the GRL, may be the document owner of briefing books to Health Authorities.
• Assist with development of the global regulatory functional plan through the research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling.
• Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols / study reports, Investigator Brochures, CMC information / data) and contribute to content as needed.
• This position has a moderate-high level of autonomy with growth opportunity. Able to work in a Fast-paced environment handling multiple demands is preferred.

Qualifications

Required

Compensation and Benefits Include :

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation : If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com . We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.