Reporting to the Executive Director, Regulatory Affairs, the Sr. Manager / Associate Director will contribute to the development and execution of an effective registrational strategy for an investigational product and/or additional indications for marketed products. The successful candidate will serve as a regulatory contact within an internal matrixed team environment, as well as with health authorities and corporate partners.
- Develop integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients
- Ensure receipt of timely and actionable health authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions
- Function as primary liaison with health authorities, including providing complete and timely responses to health authority requests for information
- Assess regulatory program risks for likelihood and impact; establish mitigation strategies
- Support product labeling efforts from inception to final negotiation
- Oversee the planning and preparation of submissions to regulatory authorities, both related to IND maintenance and marketing authorization
- Advise on regulatory requirements, expected outcomes, and changes to landscape
- Bachelor's degree in a life sciences discipline and a minimum of 5 years regulatory experience
- Oncology experience required
- Knowledge of US regulatory requirements and opportunities for expediting development programs for serious conditions
- Familiarity with labeling and CMC concepts as well as pediatric product development is desirable.
- Experience interacting with health authorities
- Able to manage conflicting priorities and adhere to tight timelines
- Able to consider and account for multiple options and opinions
- Able to travel for meetings with corporate partners and regulatory authorities
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.