Associate Director, Regulatory Affairs CMC

Location
Bothell, WA, United States
Posted
Nov 25, 2018
Ref
oCYg8fwI
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
  • Compile, review and approve high quality CMC modules of development and marketing registration applications, amendments, and supplements for submission, ensuring complete CMC content that meets current regional requirements and with limited review rounds and FDA/Health Authority questions
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports. Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
  • 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 strategic direction and regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization
  • Provide strategic support on department initiatives and policies to Regulatory Senior Management
  • Develop and implement innovative Regulatory submission and review processes for IND/IMPD/CTA/BLA/NDA and Health Authority feedback tracking to enable scale up of products developed by Seattle Genetics
  • Represent the Regulatory Affairs CMC function on assigned cross-functional project teams as well as at meetings with business partners and regulatory agencies for all CMC related issues
  • 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 to effectively influence the implementation of optimum regulatory strategies
  • Provide strategic guidance to program teams and Management on FDA and global regulatory requirements for clinical development and registration of small molecule pharmaceuticals as well as lifecycle and change management of commercial biologic products
  • Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes
  • Reviews the regulatory submissions of other associates for thoroughness, accuracy, and timeliness
  • Responsible for interactions/strategic negotiations with Regulatory Authorities to ensure that appropriate and pragmatic RA CMC positions can be negotiated with the highest probability of success
  • Represents Seattle Genetics at FDA and Health Canada meetings and initiates and responds to FDA and Health Canada contacts; builds positive and favorable relations with FDA and Health Canada. Provides input to the interactions/strategic negotiations of other associates

Qualifications:
  • BA/BS degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. Ph.D. is preferred
  • At least 7 years of experience in Regulatory Affairs
  • At least 9 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 laws.