Manager, Regulatory Affairs

Regulatory Affairs Bothell, Washington Seattle, Washington


Description

Summary: 

The Regulatory Affairs Manager will report to and support the Global Regulatory Lead for a marketed product with an expanding clinical development program, with primary responsibility for representing Regulatory on cross-functional study teams, joint meeting with external partners, and leading and supporting US regulatory submissions in line with the global regulatory plan.

Responsibilities:

Provide effective strategic and tactical regulatory support for US regulatory submission and maintenance activities, including:

  • Lead the preparation of regulatory submissions in collaboration with external partners including Clinical Trial Applications (CTAs), routine IND submissions, supplemental marketing applications, and routine reports
  • Manage the development and review of responses to health authority queries in a timely manner
  • Represent regulatory in cross-functional teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy
  • Develop and implement regulatory strategies to meet project deliverables and mitigate potential regulatory risks
  • Research relevant regulatory precedents to bring innovative approaches to the cross‑functional team and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on the commercial program
  • Maintain effective archiving and submissions/approvals tracking records
  • Assist GRL to establish processes and participate in process improvement initiatives as required

Qualifications:

  • 5+ years of relevant experience in regulatory affairs with drug or therapeutic biologic products or equivalent
  • Experience in the preparation/submission of regulatory documentation to support all regulatory submissions throughout product lifecycle
  • BS in a life sciences discipline; advance degree preferred but not required Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
  • Strong technical/analytical skills to identify and solve problems independently
  • Proven ability to manage multiple projects, identify and resolve regulatory issues
  • Ability to interpret and understand regulations in the context of the scientific and commercial environment and balance regulatory objectives with business objectives
  • Willingness to work collaboratively and incorporate diverse perspectives into decision-making
  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
  • Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting
  • Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality
  • Proactively seeks out and recommends process improvements
  • Entrepreneurial, enjoys working in a fast-paced, environment
  • Ability to work in Bothell, WA or Seattle, WA locations

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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