YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Bayer Animal Health Product Maintenance Activity Manager are to:

• Establish strategy and manage technical projects for the maintenance of existing veterinary pharmaceutical and pesticide products as part of Pharmaceutical Development;
• Ensure maintenance of existing product Chemistry Manufacturing and Controls (CMC) registrations, providing efficient and effective product maintenance activity (PMA) support during dossier submissions, change control processes, and troubleshooting;
• Establish effective collaboration and stakeholder management with global and local project management, quality, regulatory affairs, document control, manufacturing site representatives and development scientists;
• Maintain up-to-date knowledge of global regulatory requirements (FDA, EMA, EPA), guidelines (ICH, VICH), and technical developments and proactively share knowledge with globally based Pharmaceutical Development units;
• Prepare and review technical reference documents/dossiers (e.g. CMC-part, VMF, product chemistry) for submission to maintain regulatory approvals (FDA, EPA, EMA, etc.);
• Manage technical development relationships with third party contractors, manufacturers and development partners in support of product maintenance activities.

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:

• Ph.D. in Chemistry, Pharmaceutical Sciences, or related discipline with six years of pharmaceutical industry experience, M.S. in Chemistry with eight years of pharmaceutical industry experience or B.S. in Chemistry with 10 years of pharmaceutical industry experience, with significant knowledge and experience in product and/or process development;
• Demonstrated experience in one or more of the following areas:
  • Pharmaceutical product maintenance;
  • CMC regulatory affairs;
  • Drug product, formulation and/or analytical development; 
• Breadth of experience to be able to judge and decide on technical, scientific and financial topics on multiple technical projects;
• Proven technical background and understanding of EMA, FDA and EPA regulations and ICH/VICH guidelines as they apply to veterinary pharmaceutical or pesticide development;
• Excellent leadership, organizational, interpersonal, and communication skills (written and oral).  Previous work within a global organization;
• Strong computer skills including Microsoft Word, Excel, PowerPoint, MS Project and aptitude to learn new systems;
• Ability to assimilate and analytically evaluate information from multiple sources and apply critical thinking to problem solving.

Preferred Qualifications:

• Possessing a high degree of intercultural competence.