Director, Regulatory Affairs CMC

The Director, Regulatory Affairs CMC will act as a CMC regulatory representative to develop CMC regulatory strategies, submissions and compliance activities.

Responsibilities

  • Provides strategic guidance on FDA and global CMC regulatory requirements for investigational and commercial products.
  • Compiles, reviews and approves CMC modules of development and marketing registration applications, amendments, and supplements for submission.
  • Develops and implements CMC regulatory strategies for the earliest possible product approval.
  • Assists with preparation and lead meetings with Health Authorities.
  • Manages and ensures compliance with all reporting requirements, including annual and periodic reports.
  • Serves as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
  • Assesses and communicates CMC regulatory requirements to ensure all development activities are following applicable regulations and guidelines.
  • Leads and assists in preparation of Policies, Standard Operating Procedures and Work Instructions.
  • Mentors and develops regulatory talent within the regulatory department.
  • Other duties as assigned.

Qualifications

  • Provides strategic guidance on FDA and global CMC regulatory requirements for investigational and commercial products.
  • Compiles, reviews and approves CMC modules of development and marketing registration applications, amendments, and supplements for submission.
  • Develops and implements CMC regulatory strategies for the earliest possible product approval.
  • Assists with preparation and lead meetings with Health Authorities.
  • Manages and ensures compliance with all reporting requirements, including annual and periodic reports.
  • Serves as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
  • Assesses and communicates CMC regulatory requirements to ensure all development activities are following applicable regulations and guidelines.
  • Leads and assists in preparation of Policies, Standard Operating Procedures and Work Instructions.
  • Mentors and develops regulatory talent within the regulatory department.
  • Other duties as assigned.

 

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com

Equal Opportunity Employer

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