Manager/Associate Director, US Regulatory Affairs
For our client, we are seeking a Manager/associate Director, US Regulatory Affairs to join the team of a leader in the Pharmaceuticals & Biotech space. This role will drive meaningful impact across key initiatives and partner cross-functionally to deliver measurable outcomes. You will work closely with stakeholders to execute against strategic priorities and scale performance. The position offers the opportunity to influence both strategy and execution in a high-growth environment. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $140,000 – $220,000 annually
Responsibilities
- Lead regulatory strategy and submissions for FDA-CVM regulated products
- Collaborate with Global Research for early-phase regulatory input
- Define product profiles, jurisdiction, and support materials with GPM
- Assemble and coordinate responses for FDA regulatory inquiries
- Facilitate global registration activities with EU and CALAR teams
- Provide regulatory guidance for manufacturing and market initiatives
- Engage with industry working groups on FDA-CVM policy
Qualifications
- Master's or DVM/PhD in relevant scientific discipline
- 8+ years experience in US regulatory affairs and animal health
- Expertise in regulatory interpretation and application procedures
- Familiarity with veterinary product development processes
- Knowledge of FDA-CVM safety/efficacy requirements
- Desirable knowledge in biopharmaceutical product testing
- Proficient communication and negotiation skills
Benefits
- Healthcare and insurance benefits from day one
- 401K plan with matching and profit-sharing contributions
- 4 weeks of vacation for work-life balance
Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.