Senior Manager, Research and Development
Zoetis
Salary
💰 $180,000 - $250,000 per year
Job Level
Lead
About the role
- Lead Loyal’s CMC regulatory strategy, and lead company to a complete CMC dossier for our three drug products, starting with LOY-002.
- Working closely with CMC team to ensure phase-appropriate data to support successful regulatory submissions, and benefits/drawbacks of certain formulation decisions.
- Preparing technical sections and other regulatory documents for submission, including the review of protocols and reports to ensure compliance with regulations.
- Contributing to regulatory plans, strategies, and risk mitigation across the portfolio.
- Offering regulatory advice to cross-functional teams, leading the drafting of submission responses to regulatory queries, and collaborating with CMC and Quality departments for Scale-up and Post-Approval Changes.
Requirements
- Bachelor’s degree in a scientific discipline; advanced degree and RAC are pluses but not required.
- 10+ years of experience in the pharmaceutical industry, with (1) 5+ years in animal health and (2) 5+ years in small, growing biotech companies.
- Well versed in animal health CMC regulatory requirements and pharmaceutical methods for active pharmaceutical ingredients, drug products and delivery devices.
- Extensive experience writing regulatory documents including Drug Master Files and/or CMC sections submitted as part of NADA.
- Demonstrated record of successful interactions with FDA’s CVM with respect to CMC submissions.
- Comfortable looking for ways to respectfully challenge regulatory precedent while maintaining scientific excellence, integrity, and ethical conduct.
