Fortvita Biologics · 7 hours ago
Sr Director / Director of Regulatory CMC
Palo Alto, CA
Full-time
Hybrid
Director/Executive
8+ years expFortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering. Fortvita is seeking a dynamic and experienced Senior Director / Director Regulatory CMC to lead regulatory CMC strategies for clinical development through commercialization.
Biotechnology
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
Qualification
Required
A minimum of a Master's degree in life sciences. PhD or equivalent is a plus
Eight or more years of industry (Pharmaceutical, Mabs, ADC) experience
Prior work experience with US FDA or EMA is a big plus
In depth knowledge of US and ex-US regulations and filing requirements
Thorough understanding of international guidelines (ICH, cGCP) and regulations
Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts
Strong analytical, project management skills
Able to follow directions and be accountable for work assigned
Able to work independently, multi-task, and prioritize workload
Must have a team attitude and work in a matrix environment
Experience planning for and participating in Health Authority meetings
Demonstrated ability to assess and manage risk in a highly regulated environment
Demonstrated strong written, spoken and presentation communication skills
Demonstrated leadership behaviors and negotiation and influence skills
Demonstrated attention to detail
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
Benefits
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
Company
Fortvita Biologics
Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase