Sr Director / Director of Regulatory CMC

Job Description

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 Senior Director / Director Regulatory CMC to lead regulatory CMC strategies for clinical development through commercialization. The ideal candidate has experience in large molecules product development, regulatory CMC leadership, and global filing experience. The person will work in a matrix environment and lead authoring and reviewing of documents required for global regulatory submissions, in compliance with applicable regulations. This role is a hybrid model located in Palo Alto, CA.

Responsibilities

• Provide strategic CMC regulatory leadership and expertise to develop and execute regulatory strategies for global development and registration.
• Identify and communicate regulatory risks and facilitate risk mitigation strategies.
• Leads health authority interactions for CMC specific issues.
• Leads the development, writing, reviewing, and editing of CMC related technical data for inclusion in Module 3 of the common technical document (CTD). This will include information from standard operating procedures (SOPs), batch records, stability protocols, manufacturing process development, validation reports, etc for the preparation of INDs, BLAs, IMPD sections, related Module 2 summaries (QOS), briefing documents, and any other regulatory submission documents needed to support regulatory meetings, marketing applications, and life cycle management.
• Leads and manages CMC regulatory changes throughout the product life cycle.
• Performs reviews of documents prepared by other team members for completeness, accuracy, structure and grammar.
• Interprets and analyzes data related to product characterization, manufacturing process, product and process control, analytical tests, and stability while interpreting and analyzing applicable tables, listings, figures.
• Attends cross-functional meetings and works closely with process development, manufacturing, analytical, quality, and regulatory affairs team
• members to communicate document-specific timelines to ensure deliverables are completed on-time.
• Other duties as assigned

Qualifications

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.