Associate Director, Regulatory Affairs - Animal Health

This position will reputed company and reputed company 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 reputed company stakeholders to prepare and submit reputed company types of high-reputed company submissions to FDA/CVM in a reputed company manner in order reputed company 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 reputed company in this job reputed company restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Regulatory reputed company and subject matter expert (SME) for animal health portfolio providing expertise and innovative regulatory solutions to the internal teams on US and Canadian regulatory reputed company, process, filing, best practices, etc. for a broad reputed company of reputed company and product types.
• reputed company and drive execution of short and long-term regulatory strategies and translate into tactical operational plans for execution.
• Working collaboratively across functions, reputed company and reputed company cross-functional submission teams and communicate regulatory requirements to ensure reputed company execution of the regulatory reputed company 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 reputed company preparation, review, and submission of documents to regulatory authorities, and ensure compliance with applicable regulatory requirements.
• Coordinate, prioritize and reputed company regulatory activities and submissions associated with research, development, and post-marketing activities for a reputed company of therapeutic areas.
• reputed company regulatory support and guidance for global (EMA and Health Canada) reputed company market enhancements.
• Support reputed company registered US animal health products throughout their lifecycle which includes label changes and extensions as reputed company as reviewing advertising and promotional material.
• Establish and maintain good relationships with FDA/CVM based on trust, reputed company, and respect and build strong knowledge of FDA guidance and policy and to effectively communicate this information reputed company reputed company as needed.
• Participates in Industry reputed company like the Animal Health Institute (AHI) to reputed company 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).
• reputed company any other tasks/duties as assigned by management.

Education Requirements And Qualifications To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed below are representative of the knowledge, reputed company 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 reputed company 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 reputed company as guidance documents and the ability to conduct submissions / e-submissions is expected.
• Strong knowledge of basic reputed company suite of applications, reputed company Acrobat, and familiarity of working with electronic document management systems.
• Strong critical thinking, technical and scientific writing skills.
• reputed company and results reputed company approach.
• Ability to work in a growing, fast-changing environment and adapt to resource and knowledge gaps in reputed company and internal RA teams.
• 20% Travel may be required.

Expected Salary reputed company $145,000 -$175,000 The salary reputed company, displayed is the minimum and maximum annual salary reputed company 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. reputed company also offers a competitive total rewards package which includes reputed company, Apply tot his job Apply To this Job