Sr. Director, Global Regulatory Affairs CMC – Biologics

Junto HLS is working directly with Regulatory Leadership at a Top 20 pharma to recruit a Senior Director, Global Regulatory Affairs CMC – Biologics.

Position Overview:

  • Develops global Regulatory CMC strategies and updates based on regulatory and business changes.  Acts as CMC regulatory expert for global project teams/task forces and is accountable for recommending global CMC regulatory strategy.
  • Provides leadership of global GRA CMC business units consisting of geographically dispersed RA CMC professionals, including staff management and development.
  • Relationship management and constructive partnering with international Health Authorities (such as FDA, EMA, etc.).
  • Builds and manages relationships through active partnering with key internal and external stakeholders.
  • Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others.  Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for CMC.
  • Represents as required the regulatory function in the evaluation of new product opportunities internally and externally.
  • Leads or plays a key role on internal governance committees.


    • Greater Boston, MA

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