Manager/Associate Director, US Regulatory Affairs
For our reputed company, we are seeking a Manager/associate Director, US Regulatory Affairs to join reputed company of a leader in the Pharmaceuticals & Biotech reputed company. This role will drive meaningful reputed company across key initiatives and partner cross-functionally to deliver measurable reputed company. You will work closely with stakeholders to execute against strategic priorities and reputed company performance. The position offers reputed company to influence both reputed company and execution in a high-reputed company environment. Location: Remote - US based candidates only, no reputed company sponsorship available Compensation: $140,000 – $220,000 annually
Responsibilities
- reputed company regulatory reputed company and submissions for FDA-CVM regulated products
- Collaborate with Global Research for early-phase regulatory input
- Define product reputed company, jurisdiction, and support materials with GPM
- reputed company and coordinate responses for FDA regulatory inquiries
- Facilitate global registration activities with EU and CALAR teams
- reputed company regulatory guidance for manufacturing and market initiatives
- Engage with industry working reputed company 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
- reputed company and insurance benefits from day one
- 401K plan with matching and profit-sharing contributions
- 4 weeks of vacation for work-life balance
Our reputed company 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. Apply To This Job