Senior Regulatory Affairs Specialist – Animal Health

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

📋 Description

• Assist in the regulatory lifecycle processes for biologics and pharmaceutical products in the animal health sector.

• Prepare, coordinate, and manage regulatory submissions, product registrations, and associated lifecycle documentation.

• Facilitate the execution, review, and implementation of labeling strategies.

• Ensure the accuracy of regulatory documents, records, and submission tracking systems.

• Contribute to product stewardship and broader regulatory operations initiatives.

• Organize annual reports, post-approval modifications, and ongoing compliance efforts.

• Collaborate across departments to ensure the timely achievement of regulatory milestones.

• Provide assistance for additional U.S. Regulatory consulting projects as business requirements evolve.

⛳️ Requirements

• A Bachelor’s degree in a scientific discipline or a related field.

• Between 5 to 10+ years of experience in regulatory affairs or regulatory operations.

• Experience in supporting Animal Health, biologics, vaccines, pharmaceuticals, or other similar regulated products.

• Knowledge of USDA-CVB and/or FDA-CVM is preferred, but not mandatory.

• Strong organizational capabilities with an exceptional eye for detail.

• Excellent communication skills, both written and verbal.

• Demonstrated ability to manage multiple projects, deadlines, and competing priorities effectively.

• Capacity to work independently while also collaborating efficiently with cross-functional teams.

🏝️ Benefits

• Health insurance.

• Dental care.

• Vision care.

• A comprehensive benefits package emphasizing physical, emotional, financial, and social well-being.

• Support for working families, including backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.

• A range of training programs.

• Resources for professional development.

• Opportunities to engage in mentorship programs, employee resource groups, and volunteer initiatives.