Regulatory Affairs Director
4 days ago
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.
- 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.
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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Biologics CMC Regulatory Affairs Director
4 days ago
Natick, Massachusetts, United States Dechra Pharmaceuticals PLC Full timeJob Title: Biologics CMC Regulatory Affairs DirectorDechra 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...
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1 week ago
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Chief Development Officer
1 week ago
Natick, Massachusetts, United States Dechra group Full timeAbout the RoleWe are seeking a highly experienced and skilled Chief Development Officer to join our team at Dechra Group. As a key member of our leadership team, you will be responsible for ensuring the progression of our portfolio of development projects from nomination to global regulatory approval.Key ResponsibilitiesDevelop and execute successful...
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Chief Development Officer
1 week ago
Natick, Massachusetts, United States Dechra Pharmaceuticals PLC Full timeAbout the RoleWe are seeking a highly experienced Chief Development Officer to join our team at Dechra Pharmaceuticals PLC. As a key member of our leadership team, you will be responsible for ensuring the progression of our portfolio of development projects from nomination to global regulatory approval.Key ResponsibilitiesDevelop and execute successful...
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Chief Development Officer
4 days ago
Natick, Massachusetts, United States Dechra Pharmaceuticals PLC Full timeAbout the RoleWe are seeking a highly experienced and skilled Chief Development Officer to join our team at Dechra Pharmaceuticals PLC. As a key member of our leadership team, you will be responsible for ensuring the progression of our portfolio of development projects from nomination to global regulatory approval.Key ResponsibilitiesDevelop and execute...
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Chief Development Officer
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1 week ago
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11 hours ago
Natick, United States Dechra group Full timeThis is a US remote role, with a preference for candidates based in the Boston area. Invetx, a division of Dechra , is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on monoclonal antibodies (mAbs). Our proprietary innovation platform integrates leading...
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1 week ago
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