Job ID 4584 Company: Bayer Job Location Shawnee, KS
Director Regulatory Affairs (Shawnee, KS)
Job RequirementsPh.D., D.V.M., or M.S. degree and 10 plus years direct experience in medical research, clinical, regulatory affairs or other critical areas within the veterinary pharmaceutical industry;
*Must have expert knowledge of all appropriate regulations especially as they apply to preclinical and clinical disciplines to support filings;
)A thorough working experience in a regulatory affairs department with knowledge of FDA divisions, personnel, and procedural concepts;
*Good communication skills, both verbal and written;
*Prior staff management of several personnel;
*Demonstrate strong teambuilding skills;
*Should have a thorough knowledge of the pharmaceutical industry and regulated government regulations with extensive experience in dealing with consultants and clinical investigators;
*Sound leadership skills and demonstrated ability to guide projects to successful conclusions;
*Ability to influence, build relationships with regulatory bodies, and successfully negotiate;
*The ability to work within a global team framework and a multi-cultural environment;
*Displayed experiences and career achievements to be assessed as capable in the competencies of Building Effective Teams, Driving Vision and Purpose, Attracting and Developing Talent, as well as, Collaboration.
*In-depth knowledge of medical procedure, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trials.
Job DescriptionManage FDA, EPA, USDA and global Bayer partner liaisons for Bayer Animal Health, N.A. Region to assure continuing follow-up to all applications to meet Bayer's need for timely submissions and approvals;
*Direct the Regulatory Affairs staff in the planning, preparation and submission of applications to the appropriate regulatory agencies for the approval or maintenance of animal health products so that all compliance requirements are met and licenses and registrations are attained in a timely manner. This process begins in the earliest development stage and lasts throughout the life cycle of the product;
*Ensure that staff structure and activities are highly organized, but are sufficiently innovative and flexible to accommodate the many challenges that occur during the years of development and marketing of animal health products;
*Provide interpretive regulatory opinions, policy, guidance and strategies to ensure that development of new products result in expeditious approvals, meet regulatory requirements and fully exploit the capabilities of the new compound;
*Represent the company as the responsible official for all phases of regulatory submissions;
*Negotiate and obtain agreements on behalf of the company at meetings with regulatory agency officials at director levels or above;
*Interact with Bayer animal health management, corporate patent attorney's and outside companies on regulatory issues to ensure maximal achievement of global objectives;
*Act as a regulatory liaison with Bayer Animal Health AG on international registration activities for worldwide product development projects, pharmacovigilance reporting and manufacturing site approvals;
*Interact with and advise U.S. Product Supply Quality Assurance senior management in all matters concerning the FDA's oversight of the local manufacturing facilities.
*Advise the Director of Quality Assurance as well as FDA officials and investigators concerning company NADA (new animal drug application) records and procedures;
*Review written responses to FDA inspection findings and provide the Director of Quality Assurance with recommendations that ensure FDA acceptance of company responses;
*Promote the interests of Bayer Animal Health and influence improvements in the FDA regulatory processes by participation in Animal Health Institute Working Group and Leadership Committees;
*Work with the Manager of Administration in R&D in the development of regulatory affairs budgets and project schedules;
*Approve department expenditures and ensure all administrative commitments are met;
*Provide the department staff with coaching, training and career development opportunities to maximize the potential of each individual, build teamwork and problem solving skills and stimulate innovation in the workplace.
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