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.

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Summary

Fortvita is seeking a dynamic and experienced Director/ Sr Director of Regulatory Affairs to be responsible for developing and implementing global strategies to secure and maintain market approval for product(s) globally (US, EMA, Japan, Australia, Canada). This role leads the Global Regulatory Team. Serves as the primary regulatory interface with the product development team and supporting functions. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates leadership behaviors to build a cohesive team environment. Must have a solid understanding of drug development, regulatory requirements, Develops and implements accelerated submission strategies.

This role is a hybrid model located in Palo Alto, CA.

Responsibilities

Leads the GRT to development of creative global strategies in line with applicable. regulations to achieve business objectives for development and marketed products. Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests. Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products. Prepares and maintains regulatory risk assessment and mitigation strategy and communicates plan to relevant stakeholders. Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives. Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products. Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management.

Qualifications

Advanced scientific degree (i.e., PhD, MD, PharmD) or master’s degree. with at least 10 years of drug development experience. GRL experience in Oncology is a great plus. Required Experience: 10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory strategist in two or more major regions in addition to the US, such as EU. Strong global drug development foundation with business acumen. Travel expected (10%)

Compensation and Benefits Include:

Competitive base salary, bonus, and equity for all employees Actual compensation may vary depending on factors such as location, skills, experience, and performance. 401(k) retirement plan with employer matching contributions Comprehensive medical, dental, and vision insurance Generous paid time off policy, including company holidays and floating holidays

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.