Job Description
Our Client is a biopharmaceutical company based in the San Francisco Bay Area. The company specializes in antibody discovery and engineering, advancing innovative therapies designed to to treat cancer. Clinical programs are conducted in Australia, the United States, UK and the EU. These programs show promising efficacy in lung, pancreatic, and gastroesophageal cancers.
Our Client 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. The individual in this role will provide regulatory support from proof of concept, 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.
Key Responsibilities: This Individual’s primary function will be as US-Regulatory Leader 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: 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.
Global Experience is a plus.
Strong written, spoken and presentation communication.
Demonstrated attention to detail.
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.
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