Biologics CMC Regulatory Affairs Director

4 days ago


Natick, Massachusetts, United States Dechra Pharmaceuticals PLC Full time
Job Title: Biologics CMC Regulatory Affairs Director

Dechra Pharmaceuticals PLC is seeking a highly skilled Biologics CMC Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of biologics CMC global regulatory strategies for FDA, USDA, and other agency regulated programs in development and registration preparation for biologics animal health pipeline programs.

Key Responsibilities:
  • Develop and implement CMC global regulatory strategies, ensuring technical accuracy and regulatory compliance while adhering to timelines and e-submission requirements.
  • Collaborate closely with Dechra's other regulatory team members to devise robust global regulatory CMC strategies and risk mitigation for FDA, USDA, and other agency regulated programs.
  • Engage in effective communication and collaboration with cross-functional teams, within CMC and with Clinical, to coordinate efforts and achieve regulatory compliance and operational excellence.
  • Support preparation of comprehensive and stage-appropriate briefing books to enable regulatory agency interactions for CMC-related questions and topics.
  • Work with quality lead and conduct assessments of change controls and deliver regulatory evaluations of quality changes in production and quality control.
Requirements:
  • 9+ years of industry experience in CMC regulatory function
  • Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), BS/MS/Ph.D
  • Proficiency and hands-on experience in regulatory submission and approval processes from new product development to commercialization
  • Proven ability to navigate complex CMC regulatory issues and requirements effectively
  • Previous regulatory experience in biologics development, especially in monoclonal antibody-based products is preferred
  • Knowledge of animal health industry regulatory guidelines for CMC under FDA, EMA, USDA, and other regulatory agencies is essential
  • Extensive track record in the development and maintenance of regulatory CMC documents, with a strong command of regulatory standards and requirements
About Dechra Pharmaceuticals PLC:

As a people-first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial, and voluntary benefit programs are what you would expect from a recognized Best Place to Work.



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