Posted 4557 days ago
Pfizer is seeking a manager of Biological Regulatory Affairs for its Kalamazoo operation. This is a full-time regular position.
Job Description
The person hired for this position will address veterinary biological product registration needs for the United States and will be responsible for ensuring biological products are in compliance with CVB regulatory requirements.
Responsibilities
• Serve as member on multidisciplinary Project Teams responsible for developing veterinary biological products, help develop the regulatory strategy for the team, and be responsible for all US regulatory submissions for that project with significant guidance and mentoring from the Director or Senior Director.
• Serve as a liaison with Biological Discovery to help provide early regulatory input into early phase Discovery projects.
• Liaise with New Product Marketing and the TAs to conduct BOAs and BioScans, and to develop label claims and product supporting materials.
• Responsible for Production Outlines, Special Outlines and required supporting documentation.
• Liaise closely with EU and CLAR/APAC regulatory staff to facilitate global registration where appropriate.
• Serve as an alternate Liaison with USDA.
• Help provide regulatory support for reference requalification.
• Help provide regulatory support and advice regarding PGS initiatives and market enhancements.
• Help provide regulatory support of biological advertisement and promotional materials.
Qualifications
• MS in biology, animal science or other related science.
• PhD or DVM desirable.
• A minimum of 5 years experience with veterinary biological products preferably in regularly affairs or a related area.
• Strong verbal and written communication skills, and a demonstrated ability to work in a team environment.
• Understanding of the veterinary biological development process and USDA regulatory requirements desirable.
• Knowledge in the production and testing of veterinary biological products desirable.
Equal Employment Opportunity
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants.
About Pfizer Inc.
Founded in 1849, Pfizer is the world's premier biopharmaceutical. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.