Fortvita Biologics · 4 weeks ago
Sr Manager / Associate Director of Regulatory Affairs US Lead
Palo Alto, CA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
5+ years expFortvita Biologics is a biopharmaceutical company specializing in antibody discovery and engineering, targeting oncology, immunology, and neurodegenerative diseases. They are seeking a dynamic Sr Manager / Associate Director of Regulatory Affairs to ensure the execution of regional regulatory strategy in collaboration with the Global Regulatory Leader, providing regulatory support throughout the project lifecycle.
Biotechnology
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
Qualification
Required
Advanced scientific degree (i.e., PhD, MD, PharmD) or master's degree with at least 5 years of drug development experience
Experience in Oncology is a great plus
Global Experience is a plus
Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable
Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies
Strong written, spoken and presentation communication
Demonstrated attention to detail
Travel expected (10%)
Benefits
Competitive base salary, bonus, and equity for all employees.
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
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase