Senior Manager, Regulatory Affairs – Animal Health Labeling

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee labeling processes for animal health pharmaceutical and biological products throughout their entire lifecycle.

• Create and execute regulatory labeling strategies that align with compliance, product maintenance, and commercial goals.

• Prepare and coordinate labeling submissions to the FDA Center for Veterinary Medicine and the USDA Center for Veterinary Biologics.

• Assist with labeling elements, including container labels, cartons, package inserts/product circulars, administration/use instructions, shipper labels, and relevant promotional labeling.

• Direct labeling and artwork modifications from the initial stage and regulatory evaluation through to approval, implementation, and archival.

• Evaluate labeling content for regulatory adherence, consistency, and alignment with approved applications.

• Compile submission summaries, justifications, change summaries, annotated labeling, artwork components, and supporting documentation.

• Facilitate electronic submission activities utilizing Veeva Vault, eSubmitter, and the USDA NCAH Portal.

• Act as a regulatory liaison for health authority inquiries, deficiencies, commitments, and approvals.

• Monitor submission milestones, agency feedback, implementation requirements, and labeling histories.

• Evaluate proposed labeling amendments and determine suitable regulatory strategies and reporting categories.

• Assist with lifecycle activities such as safety updates, manufacturing modifications, product line extensions, market expansion, and product discontinuation.

• Offer regulatory labeling guidance and technical support to cross-functional teams.

• Keep abreast of emerging regulations and pinpoint opportunities to enhance labeling processes and submission efficiencies.

• Support various U.S. regulatory programs and client engagements as business needs change.

• Collaborate closely with Regulatory Affairs, Quality, Manufacturing, Marketing, Supply Chain, Pharmacovigilance, and other cross-functional stakeholders.

⛳️ Requirements

• A Bachelor’s degree in a scientific, regulatory, veterinary, pharmaceutical, or related field.

• Extensive regulatory affairs experience in pharmaceuticals, biologics, vaccines, animal health products, or similar regulated items.

• Proven experience with product labeling, regulatory submissions, and lifecycle management.

• In-depth knowledge of labeling compliance, artwork change control, and regulatory documentation.

• Ability to work autonomously, handle competing priorities, and provide assertive regulatory guidance.

• Excellent written and verbal communication, organizational, and stakeholder management abilities.

• Experience functioning effectively in a client-facing and cross-functional setting.

• Preferred: ten or more years of relevant regulatory affairs experience.

• Preferred: direct experience with animal health pharmaceutical and biological products.

• Preferred: experience preparing submissions for FDA-CVM and USDA-CVB.

• Preferred: familiarity with Veeva Vault, eSubmitter, and the USDA NCAH Portal.

• Preferred: experience in direct communication with U.S. health authorities.

• Preferred: experience providing technical leadership, training, or mentoring within regulatory teams.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Backup dependent care support.

• Adoption assistance programs.

• Infertility coverage options.

• Family building support resources.

• Solutions for behavioral health issues.

• Paid parental leave benefits.

• Paid caregiver leave.

• Training programs available.

• Resources for professional development.

• Mentorship opportunities.

• Employee resource groups.

• Volunteer activities.