Director/Sr. Director, Regulatory Policy

Location
Bothell, WA, United States
Posted
Nov 13, 2018
Ref
oscO8fwk
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Summary:

The Director/Sr. Director, Regulatory Policy will oversee the strategic assessment and communication of changes to regulatory policies and collaborate with internal and external stakeholders to evaluate the impact and relevance to the Company's global drug development programs and regulatory strategies. The role will be primarily focused on US policy, with expansion to global policy as a secondary component. The Director/Sr. Director, Regulatory Policy will also oversee the Regulatory Intelligence function.

Responsibilities:
  • Monitor relevant draft legislation, guidance, and other sources of regulatory information from Health Authority webpages and public databases, conferences, workshops, and biopharma trade associations
  • Communicate new and emerging regulatory requirements and key insights and intelligence to regulatory leadership and cross-functional colleagues
  • Oversee the strategic assessment of external regulatory changes globally and work with subject matter experts within the Company to align on consensus positions/responses as well as anticipate implications of important emerging regulatory requirements and political environment on Company projects and business
  • Build and maintain relationships with industry stakeholders (eg, biopharma trade associations, biopharmaceutical companies, regulatory authorities) to gather insights that inform business objectives
  • Represent Regulatory Policy and provide leadership for internal and external forums/networks
  • Drive best practices and excellence in execution within the regulatory department and cross-functionally to meet business needs


Qualifications:
  • Bachelor's degree in a life sciences discipline; advanced science-related degree preferred
  • 10+ years in the pharmaceutical industry; 5+ years of relevant global regulatory experience
  • Deep understanding of global regulatory requirements governing drugs and biologics in all phases of development, including post-marketing
  • Knowledge of global health authority organization and process, including key regulatory policy issues; experience developing regulatory strategies reflecting global health authority thinking
  • Ability to understand and interpret complex scientific issues across projects as they relate to regulatory requirements, regulatory intelligence, policy and strategy for the region
  • Ability to communicate new or evolving changes in regulatory requirements to a broad internal audience and provide strategic input to cross-functional teams
  • Ability to partner effectively across all levels of the company and to successfully influence and advocate on behalf of the company's regulatory policy priorities
  • Outstanding written and oral communication skills as well as managing and adhering to timelines


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.