Manager, Regulatory Affairs CMC

Location
Bothell, WA, United States
Posted
Sep 26, 2018
Ref
owYg8fwC
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Responsibilities:
  • Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of one or more products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy and ensure complete CMC content that meets current regional requirements
  • Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and providing strategic regulatory guidance for optimal implementation of changes
  • Research and interpret global CMC regulations and provide regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization
  • Represent the Regulatory Affairs CMC function on assigned cross-functional project teams
  • Manage interactions with global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information
  • Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners


Qualifications:
  • BA/BS degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. Ph.D. is preferred
  • At least 3 years of experience in Regulatory Affairs
  • At least 5 years in a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and both development and commercial phases of product lifecycle)
  • Strong working knowledge of U.S. and EU regulatory requirements for biologics and small molecules, with preference for antibody drug conjugates
  • Experience in preparation of clinical trial applications, marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S., Canada and Europe using eCTD format
  • Experience in assessing post-marketing changes
  • Outstanding interpersonal and communication (written and verbal) skills is required
  • Demonstrated ability to work within a cross-functional matrix team environment, such as cross-functional groups in Quality and Manufacturing, and including contractors, partners, and CRO's in the international markets
  • Highly organized, independent, self-motivated and able to meet deadlines
  • Proficiency with standard software programs (e.g., Word)
  • Project management skills are a plus


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.