Director/Senior Director, Regulatory Affairs CMC

The Director/Senior 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

  • 10+ years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 5 years in Chemistry, Manufacturing and Control (CMC) regulatory environment, Oncology experience preferred.
  • Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred.
  • Experience in working directly with key regulatory agencies (FDA, EMA) on innovative NCE and NBE. 
  • Demonstrated experience in CMC in bringing developmental assets to commercial stage
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and marketed products.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
  • Prior experience with NDA/BLA submission is strongly preferred. 

Job Location: Cambridge, MA

Equal Opportunity Employer

California residents, please visit www.SDPOncology.com/CAprivacynotice for information on our privacy practices.