Senior Director, Regulatory Affairs CMC

6 days ago


Woburn, Massachusetts, United States Replimune, Inc. Full time
Job Title: Senior Director, Regulatory Affairs CMC

Replimune, Inc. is seeking a highly experienced Senior Director, Regulatory Affairs CMC to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing CMC regulatory strategies and activities.

Key Responsibilities:
  • Develop and execute CMC regulatory strategies and activities to ensure timely preparation, review, and submission of CMC documents to regulatory authorities.
  • Collaborate with development partners to ensure compliance with applicable regulatory requirements.
  • Work with cross-functional teams to manage activities and changes related to product development, manufacturing, and commercialization.
  • Manage external regulatory consultants and project deadlines.
  • Ensure compliance with company standards and applicable US and international regulations.
Requirements:
  • 15+ years of experience in Pharmaceutical/Biotech Industry with 10+ years in a CMC Regulatory Affairs capacity.
  • Strategic leader with demonstrated success building, managing, and developing teams.
  • Professional knowledge and skills working with solid tumor oncology therapeutics.
  • Excellent written and verbal communication skills, with a willingness to be hands-on and not delegate responsibilities.
  • Previous experience in representing the sponsor in front of regulatory agencies and as primary regulatory author for IND and CTA documents.
Preferred Qualifications:
  • Expedited approval pathway, rare disease, and commercial experience.
  • Highly knowledgeable in ICH, FDA, and EMA regulations and guidelines.
  • Skilled in multiple computer-based tools, including MS Office.
Location:

This position can be based in our Woburn Corporate office, which maintains a hybrid schedule, or it can be staffed remotely.



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