Senior Associate Specialist, Regulatory Operations

Senior Associate Specialist, Regulatory Operations

This role offers the opportunity to support the advancement of innovative veterinary therapeutics through high-quality regulatory operations and submission management. You will play a key role in preparing, organizing, and maintaining regulatory documentation that supports complex approval pathways. The position combines technical regulatory expertise, operational ownership, and cross-functional collaboration with scientific and development teams. You will contribute directly to building regulatory foundations for emerging treatments while helping establish new standards within the field.

The ideal candidate is detail-oriented, proactive, and comfortable managing submissions, systems, and timelines in a fast-moving environment. This is an impactful opportunity for a regulatory operations professional who enjoys solving complex challenges and contributing to groundbreaking healthcare innovation.

Accountabilities:

The Senior Associate Specialist, Regulatory Operations will support regulatory submission activities by ensuring accurate preparation, organization, and delivery of regulatory materials. The role requires strong attention to detail, ownership of regulatory systems, and collaboration across scientific and operational teams to keep programs moving efficiently.

• Assist with the preparation, review, formatting, and organization of clinical and CMC regulatory submissions and reports.
• Compile and package regulatory submissions using electronic submission platforms, ensuring accuracy and compliance with requirements.
• Assemble, publish, and submit regulatory documentation to relevant agencies, including technical sections, amendments, annual reports, meeting requests, and related correspondence.
• Manage electronic submission processes, including account administration, submission tracking, receipt reconciliation, and troubleshooting transmission issues.
• Maintain regulatory archives, correspondence logs, and documentation systems to ensure information can be quickly accessed during review cycles or inspections.
• Own regulatory document templates, formatting standards, and submission style guidelines.
• Create and maintain submission trackers while ensuring regulatory activity records remain accurate and up to date.
• Collaborate with Research, Clinical Development, CMC, and other cross-functional teams to coordinate submission content and timelines.
• Support product labeling activities and regulatory documentation requirements.
• Monitor regulatory updates and evolving requirements from relevant authorities to ensure continued compliance.
• Independently manage assigned regulatory operations activities while aligning with broader regulatory strategies and priorities.

The ideal candidate has hands-on regulatory operations experience and understands the requirements involved in preparing and submitting regulatory documentation. Successful candidates will combine technical knowledge, organizational skills, and the ability to collaborate effectively across multidisciplinary teams.

• Bachelor's degree in biology, veterinary medicine, regulatory affairs, life sciences, or a related field; relevant professional experience may be considered in place of a specific degree.
• 3–5 years of regulatory operations experience within human health, animal health, biotechnology, pharmaceuticals, or related industries.
• Experience preparing, formatting, packaging, and submitting regulatory documentation.
• Hands-on experience with electronic regulatory submission systems, including FDA electronic submission processes.
• Knowledge of regulatory submission types and processes, including IND/INAD, NDA/NADA, biologics submissions, meeting requests, supplements, and related filings.
• Understanding of regulatory documentation standards and submission lifecycle management.
• Experience collaborating with cross-functional teams, including Research, Clinical Development, CMC, and Regulatory Affairs.
• Ability to manage multiple priorities, maintain accurate records, and meet deadlines in a dynamic environment.
• Strong attention to detail with excellent organizational and documentation skills.
• Ability to…