Sr. Manager/ Associate Director, Regulatory Labeling Lead

Location
San Francisco, CA, United States
Posted
Nov 30, 2018
Ref
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Required Education
Bachelors Degree
Position Type
Full time
Summary:

The labeling lead will develop and drive labeling strategy for both marketed and investigational products. Success in the role will come from a complete understanding of the strategic objectives of each program, an effort to remain current on regional labeling regulations and precedence, and the integration of the two to provide compliant and informative prescribing information. This role will lead a cross-functional Label Working Group and advise on labeling matters as a member of regulatory and submission subteams.

Responsibilities:
  • In partnership with the program Regulatory Lead, incorporates target product labeling concepts early into priority development programs
  • Leads program teams through the development and maintenance of a company core data sheet, refining labeling scenarios and strategy as data mature
  • Chairs the Label Working Group to draft and revise region-specific labeling content that is aligned with the company core data sheet; facilitates the Label Committee review and approval of labeling prior to submission to Health Authorities
  • Ensures alignment with the labeling strategy across all registrational dossier components
  • Prepares labeling components for submission in registrational dossiers and prepares program teams for labeling negotiations with Health Authorities
  • Contributes to developing, maintaining and executing against an efficient global labeling process
  • May perform regulatory review of non-promotional medical and scientific communications


Qualifications:
  • Bachelor's degree in a life sciences discipline
  • Minimum of 7 years regulatory affairs or related experience within the pharmaceutical industry
  • Regulatory submission experience
  • Understanding of North American and EU labeling requirements
  • Strong writing and word processing skills
  • Detail oriented, well organized, able to plan to and deliver against tight timelines
  • Able to lead cross-functional discussions, including with corporate partners, and drive to results
  • Oncology experience preferred
  • Able to travel for meetings with corporate partners


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.