Manager/Associate Director, US Regulatory Affairs
Zoetis
2 months ago
Remote friendly (Michigan, United States)
United States
Corporate Functions
Key responsibilities:
- Serve as regulatory subject matter expert on multidisciplinary (food and companion animal) teams developing veterinary pharmaceutical/biopharmaceutical products; develop and implement US regulatory strategy and own US FDA submissions/interactions for assigned projects.
- Provide early regulatory input for early-phase projects (liaison with Global Research/VMRD).
- Partner with GPM and Therapeutic Area Leads on product profiles, regulatory jurisdiction, label claims, support materials, and project documentation.
- Assemble original and supplemental US applications; coordinate responses to regulatory authority questions; liaise with FDA-CVM as needed.
- Liaise with EU and CALAR regulatory staff to support global registrations (as appropriate).
- Provide regulatory support/guidance for Global Manufacturing initiatives and commercial market enhancements.
- Participate in industry working groups with FDA-CVM on current/proposed policy and regulation.
Qualifications/requirements:
- Master’s or DVM and/or PhD in a relevant scientific discipline (e.g., animal science, veterinary medicine, immunology, toxicology/pharmacology).
- 8+ years’ experience in US regulatory affairs within an animal health discipline with FDA-CVM interaction.
- Demonstrated regulatory interpretation/procedures for phased, original, and supplemental applications.
- Knowledge of veterinary medicinal product development process; safety/efficacy and FDA-CVM dossier assembly.
- Desirable: experience with production/testing of biopharmaceutical veterinary products.
- Excellent oral/written communication and negotiation; ability to multitask in a global (virtual) team.
- Fluency in English; strong Microsoft Office skills.
Compensation/benefits:
- US base salary range: $140,000–$220,000.
- Eligible for short-term and long-term incentives; healthcare/insurance (from day one), 401K match and profit-sharing, and 4 weeks’ vacation.
- Serve as regulatory subject matter expert on multidisciplinary (food and companion animal) teams developing veterinary pharmaceutical/biopharmaceutical products; develop and implement US regulatory strategy and own US FDA submissions/interactions for assigned projects.
- Provide early regulatory input for early-phase projects (liaison with Global Research/VMRD).
- Partner with GPM and Therapeutic Area Leads on product profiles, regulatory jurisdiction, label claims, support materials, and project documentation.
- Assemble original and supplemental US applications; coordinate responses to regulatory authority questions; liaise with FDA-CVM as needed.
- Liaise with EU and CALAR regulatory staff to support global registrations (as appropriate).
- Provide regulatory support/guidance for Global Manufacturing initiatives and commercial market enhancements.
- Participate in industry working groups with FDA-CVM on current/proposed policy and regulation.
Qualifications/requirements:
- Master’s or DVM and/or PhD in a relevant scientific discipline (e.g., animal science, veterinary medicine, immunology, toxicology/pharmacology).
- 8+ years’ experience in US regulatory affairs within an animal health discipline with FDA-CVM interaction.
- Demonstrated regulatory interpretation/procedures for phased, original, and supplemental applications.
- Knowledge of veterinary medicinal product development process; safety/efficacy and FDA-CVM dossier assembly.
- Desirable: experience with production/testing of biopharmaceutical veterinary products.
- Excellent oral/written communication and negotiation; ability to multitask in a global (virtual) team.
- Fluency in English; strong Microsoft Office skills.
Compensation/benefits:
- US base salary range: $140,000–$220,000.
- Eligible for short-term and long-term incentives; healthcare/insurance (from day one), 401K match and profit-sharing, and 4 weeks’ vacation.