Senior Specialist Regulatory Affairs
Merck’s Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.
Merck Animal Health, DeSoto, KS is a BioTechnology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals. As a member of the Regulatory Affairs Biologics team, the Senior Specialist is responsible but is not limited to the following duties:
- Regulatory species sub-team leader responsible for pre-and post licensure activities
- Manages direct reports in support of regulatory submissions, performance management goals and priorities.
- Represents Merck Animal Health in communications and submissions to the USDA as an Alternate Liaison.
- Subject matter expert for regulatory procedures and serve as regulatory stakeholder for internal change controls.
- Review, prepare and approve regulatory documents for USDA government submission.
- Provide scientific guidance to the regulatory team on new and upcoming technologies proposed for manufacture of vaccines.
- Assists with obtaining documents and creation of standard international dossiers for International registration of vaccines.
Education Minimum Requirement:
Bachelor’s degree in a relevant discipline such as molecular biology, animal science, veterinary technology, immunology, regulatory or law with a minimum of 5 years of regulatory or vaccine experience or Master’s degree in a relevant discipline with 3 years of regulatory or vaccine experience.
Required Experience and Skills**:
- Knowledge of USDA requirements and regulations relating to manufacturing of biological vaccines.
- Knowledge of molecular biology
- Computer skills and working knowledge of Microsoft Office
- Excellent written and verbal communication skills
- Ability to demonstrate clear motivation and focus on achieving measurable and tangible results.
Preferred Experience and Skills:
- Prior animal health regulatory experience
- Supervisory experience
- Practical veterinary or animal science experience
- Knowledge of animal health product development
- Knowledge and understanding of the animal health sector
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Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Visa sponsorship is not available for this position.
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