Associate Director, Regulatory Affairs CMC

Location
Morris Plains, NJ
Posted
Jun 26, 2022
Ref
2992306
Required Education
Masters Degree/MBA
Position Type
Full time

Gilead Sciences, Inc is recruiting for an Associate Director in the Regulatory Affairs CMC department. The successful candidate may lead a small team of RACMC specialists focused on regulatory guidance and the delivery of components for clinical trial applications, marketing applications, and post-authorization submissions for biological substances and products. The successful candidate will serve as the RACMC regional lead on cross-functional teams with several subject-matter experts as well as lead regulatory submission teams.

Job Responsibilities:

  • Responsible for preparing and/or overseeing the preparation of technically complex biologics regulatory CMC submissions which require extensive interaction with departments outside of Regulatory Affairs CMC for investigational and commercial products, in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and BLA's/MAAs for assigned territories.
  • Work with the regional CMC personnel to develop a CMC submission plan in accordance with business objectives.
  • Lead the development of the Regulatory CMC strategy, content, and submission timelines in accordance with business objectives.
  • Provides strategic regulatory CMC advice for biologics submissions.
  • Ensure cross-regional communication and transparency in the flow of CMC information that may affect regional regulatory strategy.
  • Coordinate and facilitate development of regional Regulatory CMC strategy with affiliates for local meetings and interactions.
  • Ensures up-to-date knowledge of regulatory biologics CMC. requirements and communicates relevant changes in regulatory information to project teams and senior management in a timely manner.
  • Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or other departments.
  • Elevate CMC issues and potential risks, along with possible resolutions, to senior management especially when such issues impact the approvability of submissions and/or product launch.
  • Facilitate good teamwork across affiliates and sites.


Knowledge and Skills:

  • Excellent technical skills and understanding of biological process development and pos-marketing changes to an approved complex biological product.
  • Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines.
  • Excellent verbal and written communication skills and interpersonal skills.
  • In-depth knowledge of biologics regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs CMC.
  • Capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
  • Capable of assuming leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and of actively participating in a broader cross functional team for implementation of major changes (region specific).
  • Capable of leading a team in preparation of complex regulatory submissions and maintenance of licenses.
  • Work is performed under consultative direction towards corporate regulatory goals and objectives.
  • Is recognized as a knowledgeable resource for biologics CMC Regulatory Advice in other departments.


Education and Experience:

  • 8-10+ years of experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.
  • Degree in a biologics scientific, technical field is preferred.
  • People management experience is desired.



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