Bayer Animal Health Associate Manager of Regulatory Affairs

Bayer   •  

Shawnee, KS

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 36 days ago

Your tasks and responsibilities

The primary responsibilities of this role, Bayer Animal Health Associate Manager of Regulatory Affairs, are to:

  • Represents the company on development project teams for Food and Drug Administration, United States Department of Agriculture (USDA), or other regulatory pathway programs. Either independently or together with group management, communicates with regulatory agency officials concerning requirements for obtaining approvals of submissions. Communicates current regulatory requirements and provides direction and insight to middle and upper management;
  • 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 Food and Drug Administration-Center for Veterinary Medicine (FDA-CVM), United States Department of Agriculture- Center for Veterinary Biologics (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;
  • Tracks the payment of regulatory authority fees as pertinent to projects and facilitates budgeting for and payment of the fees with Research and Development (R&D) Administration;
  • Assists activities of regulatory affairs maintenance projects or innovation projects assigned to other associates when required;
  • When required, prepares dossiers for product registrations outside the US and coordinates registration change control.

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:

Required Qualifications:

  • Bachelor of Science in related science area with ten years’ relevant experience, Master of Science in related science area with six years’ relevant experience, or Doctor of Veterinary Medicine (DVM) or Doctor of Philosophy (PhD) with four years’ relevant experience;
  • Must have advanced knowledge of applicable federal regulations, procedures and policies with experience interacting with FDA- CVM, USDA-CVB, and other regulatory authorities as needed;
  • Must have intermediate knowledge of pertinent guidelines and federal regulations (Good Manufacturing Practices (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), VICH) under which products are evaluated;
  • Must be detail oriented with strong organizational, interpersonal, and communication skills and ability to coordinate large regulatory projects;
  • Good computer skills (e.g., Microsoft Word and Adobe Acrobat, PowerPoint, Microsoft Project, FDA-CVM eSubmitter), and 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 Critical Competencies: Collaborates, Plans and Aligns.