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 animal health biologics and pharmaceutical products.

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

• Aid in the execution, review, and implementation of labeling strategies.

• Ensure the maintenance of precise regulatory documentation, records, and submission tracking.

• Contribute to product stewardship and broader regulatory operations tasks.

• 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

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

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

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

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

• Strong organizational abilities with outstanding attention to detail.

• Excellent written and verbal communication skills.

• Proven capability to manage multiple projects, meet deadlines, and handle competing priorities.

• Ability to work independently while effectively collaborating with cross-functional teams.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.

• Remote work options.

• Backup dependent care.

• Adoption assistance.

• Infertility coverage.

• Family building support.

• Behavioral health solutions.

• Paid parental leave.

• Paid caregiver leave.

• Training programs.

• Professional development resources.

• Mentorship programs.

• Employee resource groups.

• Volunteer activities.