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. This involves providing regulatory guidance and experience, facilitating meetings and discussions with FDA/CVM, and working with internal and external stakeholders to prepare and submit all types of high-quality submissions to FDA/CVM in a timely manner in order gain the most efficient approvals and launch new products on schedule. The position may include the supervision and management of regulatory professionals and support personnel. Essential Duties And Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Regulatory lead and subject matter expert (SME) for animal health portfolio providing expertise and innovative regulatory solutions to the internal teams on US and Canadian regulatory strategy, process, filing, best practices, etc. for a broad range of projects and product types.
• Develop and drive execution of short and long-term regulatory strategies and translate into tactical operational plans for execution.
• Working collaboratively across functions, develop and lead cross-functional submission teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy throughout the product life cycle.
• 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.

Education Requirements And Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Minimum Requirement: Bachelor's or Master's degree in a relevant scientific discipline such as animal science, immunology, toxicology/pharmacology required. DVM or equivalent or PhD is desirable.

• Minimum 8 Years regulatory affairs, clinical and/or chemistry experience in the animal health industry and FDA CVM with working knowledge of GCP, GLP, and GMP required.
• 5+ years of experience in a supervisory or managerial role required.
• Knowledge of animal health product development and understanding of the animal health sector.
• Intimate knowledge of regulations, as well as guidance documents and the ability to conduct submissions / e-submissions is expected.
• Strong knowledge of basic Microsoft suite of applications, Adobe Acrobat, and familiarity of working with electronic document management systems.
• Strong critical thinking, technical and scientific writing skills.
• Collaborative and results focused approach.
• Ability to work in a growing, fast-changing environment and adapt to resource and knowledge gaps in client and internal RA teams.
• 20% Travel may be required.

Expected Salary Range $145,000 -$175,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, Apply tot his job Apply To this Job