Bayer Animal Health Regulatory Affairs Specialist
Your tasks and responsibilities
The primary responsibilities of this role, Bayer Animal Health Regulatory Affairs Specialist are:
- Represents the company on development project teams for FDA, USDA, or other regulatory pathway programs. Together with group management, communicates with regulatory agency officials concerning requirements for obtaining approvals of submissions;
- Develops current knowledge of regulatory requirements by continued review of regulations, new guidelines, and trade publications, as well as by participating in the working groups of trade associations such as the Animal Health Institute where appropriate;
- Develops and maintains knowledge and skills in electronic submissions to FDA-CVM, USDA-CVB, or other regulatory authorities as required;
- Participates in several product development projects simultaneously; has a direct impact on our regulatory strategy to influence agency decisions; is responsible for assuring the projects assigned are carried out in full compliance with government regulations, and is responsible for assuring that the regulatory aspects of these projects are completed accurately and in a timely manner;
- Assists with activities of regulatory affairs maintenance projects or innovation projects as required;
- Coordinates with other team members on dossiers for product registrations outside the US and registration change control as required.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- BS in related science area with six plus years relevant experience; MS in related science area with four plus years relevant experience; or DVM or PhD with two plus years relevant experience;
- Must demonstrate understanding of applicable federal regulations, procedures and policies with experience interacting with FDA-CVM, USDA-CVB, and other regulatory authorities as needed;
- Must have basic knowledge of pertinent guidelines and federal regulations (GMP, GCP, GLP, and VICH) under which products are evaluated;
- Highly detail oriented with strong organizational, interpersonal, and communication skills with a proven ability to coordinate large regulatory projects;
- Proven computer skills with Microsoft Office applications including Word, PowerPoint, and Excel, Microsoft Project as well as Adobe Acrobat and FDA-CVM eSubmitter. Incumbent must possess an aptitude to learn new systems;
- Must work well in cross-functional teams;
- Sound decision-making capabilities are required;
- Willing to travel to US and international locations (approximately 15% of time).
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Location: KS-Shawnee Mission
Functional Area: [sap_fa_32]
Entry Level: 5