Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Bayer Animal Health Associate Manager of Regulatory Affairs

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.

 

 

 

 

 

 

 

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

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.

 

Country: United States
Location: KS-Shawnee Mission