Senior Director, Regulatory Affairs CMC

1 month ago


Woburn, Massachusetts, United States Replimune, Inc. Full time
Job Summary

We are seeking a highly experienced Senior Director, Regulatory Affairs CMC to join our team at Replimune, Inc. This role will be responsible for developing and executing CMC regulatory strategies and activities, ensuring timely preparation, review, and submission of CMC documents to regulatory authorities.

Key Responsibilities:
  • Develop and execute CMC regulatory strategies and activities to ensure compliance with applicable regulatory requirements.
  • Oversee the development and implementation of global regulatory strategies, including the preparation, review, and submission of CMC documents to regulatory authorities.
  • Collaborate with development partners, regulatory subject matter experts, and other stakeholders to ensure a fully integrated regulatory strategy.
  • Manage external regulatory consultants and project deadlines to ensure timely completion of regulatory submissions.
  • Ensure compliance with company standards and applicable US and international regulations.
Requirements:
  • A minimum of 15 years of experience in the Pharmaceutical/Biotech Industry, with 10+ years in a CMC Regulatory Affairs capacity.
  • Strategic leadership experience, with a proven track record of building, managing, and developing teams.
  • Professional knowledge and skills working with solid tumor oncology therapeutics, with biologic, gene therapy, or vaccine experience preferred.
  • Excellent written and verbal communication skills, with the ability to interact directly with global regulatory agencies.
  • Strong interpersonal, organizational, and time management skills, with attention to detail.
What We Offer:
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

We are an Equal Opportunity Employer and welcome applications from diverse candidates.



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