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Director/Sr Director, Regulatory Affairs CMC

Company: Sumitomo Dainippon Pharma Oncology
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Director/Sr Director, Regulatory Affairs CMC The 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 the 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 the 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. Dedicated to the Promise of Purposeful Science At Sumitomo Dainippon Pharma Oncology, we are advancing meaningful therapeutic options for patients with cancer. Through scientific persistence and a commitment to discovery, we are focused on pursuing a diverse and purposeful pipeline.
      Learn more about our pipeline . Privacy Notice Sumitomo Dainippon Pharma Oncology is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.

Keywords: Sumitomo Dainippon Pharma Oncology, Cambridge , Director/Sr Director, Regulatory Affairs CMC, Executive , Cambridge, Massachusetts

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