Associate/Sr.  Director, Regulatory Affairs

Location
Bothell, Washington State (US)
Salary
Competitive salary and benefits
Posted
Apr 25, 2018
Closes
Jun 25, 2018
Education
BS
Career Fair Category
Career Fair

<p>Seattle Genetics is passionate about making a positive impact on the lives of patients with cancer. Employees bring that enthusiasm to everything they do, striving to attain their individual goals while recognizing the power of working collaboratively to realize Seattle Genetics' vision of improving patient outcomes. View this career recruitment video to learn about Seattle Genetics' culture and hear directly from chemists, clinical researchers and sales professionals. As a company working at -- and advancing -- the cutting edge of antibody-based therapies, Seattle Genetics fosters an environment that recognizes the challenges of breaking new ground and creates opportunities for intellectual and professional growth. State-of-the art facility gives our team members the resources to succeed. Located in Bothell's Canyon Park area, Seattle Genetics is close to major highways, dining and shopping. If you are passionate about bringing the best of yourself to everything you do, Seattle Genetics offers challenges, opportunities and rewards for making your best even better. We want to hear from you!</p>

Associate/Sr.  Director, Regulatory Affairs

Summary:

Reporting to the Executive Director or Executive VP, Regulatory Affairs, the Associate Director will contribute to the development and execution of an effective registrational strategy for investigational products 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.

Responsibilities:

  • 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

Qualifications:

  • Bachelor’s degree in a life sciences discipline and a minimum of 7 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 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.