American Regent, Inc. · 8 hours ago
Associate Director, Regulatory Affairs - Animal Health
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$145K/yr - $175K/yr
8+ years expAmerican Regent, Inc. is focused on animal health and is seeking an Associate Director for Regulatory Affairs. This role will lead and develop regulatory strategies for new animal products, ensuring compliance with FDA/CVM regulations and managing submissions to facilitate product approvals.
Health CareMedical
Responsibilities
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
Qualification
Required
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
Benefits
Healthcare
Life insurance
Profit sharing
Paid time off
Matching 401k
A wide Range Of Other Benefits
Company
American Regent, Inc.
American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Paul Diolosa
President & CEO
Joseph Boyle
VP Finance / CFO
Recent News
GlobeNewswire
2026-01-09
thefly.com
2025-08-28
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