Regulatory Affairs Director

4 days ago


Natick, Massachusetts, United States Dechra Pharmaceuticals PLC Full time
About the Role

We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at Dechra Pharmaceuticals PLC. As a key member of our regulatory team, you will be responsible for developing and executing successful regulatory strategies to achieve agreed project goals, ultimately leading to regulatory approvals.

Key Responsibilities
  • Prepare regulatory input to development plans, pilot and pivotal protocols, and study reports.
  • Engage regularly and effectively with regulatory agencies to ensure development plans are robust, aligned with regulation, agency expectations, and guidances.
  • Execute regulatory filings to ensure development programs remain on track through pre-clinical, pilot, and pivotal programs.
  • Assist the Chief Development Officer to develop appropriate regulatory strategies leading to approval of Invetx's product candidates, particularly those aspects related to the USDA regulatory pathway.
  • Collaborate with Discovery, Clinical, and CMC personnel to ensure seamless and efficient progression of early-stage candidates from research to proof of concept to clinical development and ultimately, to approval.
Requirements
  • 5+ years of experience within the Animal Health pharmaceutical industry, with 2+ years in a regulatory position, preferably focused on the USDA regulatory pathway.
  • 5+ years of experience participating in cross-functional teams.
  • MS in a biological discipline.
  • Experience collaborating with regulatory agencies and other partners.
  • Proven success in achieving objectives comparable to those of this position.
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 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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