Associate Director, Regulatory Affairs - Animal Health

This position will lead and develop animal health regulatory strategies, objectives, policies and programs pertaining to the development of new animal products in the US and other emerging markets. The position may include the supervision and management of regulatory professionals and support personnel.

Requirements

• Regulatory lead and subject matter expert (SME) for animal health portfolio
• Develop and drive execution of short and long-term regulatory strategies and translate into tactical operational plans for execution
• Write and manage regulatory submissions, such as new INADs, IDEs, annual reports, clinical and nonclinical protocols, and other submissions as required
• Ensure timely preparation, review, and submission of documents to regulatory authorities, and ensure compliance with applicable regulatory requirements
• Coordinate, prioritize and track regulatory activities and submissions associated with research, development, and post-marketing activities for a variety of therapeutic areas
• Provide regulatory support and guidance for global (EMA and Health Canada) commercial market enhancements
• Support current registered US animal health products throughout their lifecycle which includes label changes and extensions as well as reviewing advertising and promotional material
• Establish and maintain good relationships with FDA/CVM based on trust, integrity, and respect and build strong knowledge of FDA guidance and policy and to effectively communicate this information within the company as needed
• Participates in Industry groups like the Animal Health Institute (AHI) to provide input to help shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations
• Maintain knowledge of changing regulatory requirements and advise teams as appropriate (Regulatory Intelligence)
• Perform any other tasks/duties as assigned by management

Benefits

• Healthcare
• Life insurance
• Profit sharing
• Paid time off
• Matching 401k