Animal Health Regulatory Affairs Sr. Manager

Nature and Scope 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 SME for animal health projects providing expertise and innovative solutions to the internal teams on US and Canadian regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications. Develop and drive execution of short and long-term regulatory strategies and translate into tactical operational plans for execution. 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 INDs, IDEs, annual reports, Investigator's Brochure, clinical and nonclinical protocols, NDA/ANDA/BLA, MAAs, 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. To 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). Actively trains/mentors’ junior staff; provides broader guidance on regulatory interpretation to ARI staff. 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, veterinary technology, immunology, toxicology/pharmacology. Minimum 5 Years chemistry, clinical and/or regulatory affairs preferably in the animal health industry and FDA CVM with working knowledge of GCP, GLP, and GMP. 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 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. Excellent skills in moderating and presentation. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com. Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.