Senior Specialist – Regulatory Science

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

📋 Description

• Assist with US labeling initiatives for pharmaceutical and biological products in Animal Health.

• Oversee the development, review, approval, implementation, and upkeep of labeling.

• Prepare and coordinate regulatory submissions, registrations, annual reports, and post-approval modifications.

• Provide support for regulatory operations, document workflows, submission tracking, and records management.

• Maintain regulatory documentation, correspondence, trackers, and product details.

• Assist with lifecycle management and product stewardship initiatives.

• Assess changes in product, labeling, manufacturing, and quality for potential regulatory implications.

• Collaborate with teams in Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, and Commercial sectors.

• Facilitate onboarding, training, knowledge transfer, and regulatory system functions.

• Ensure all assigned tasks adhere to relevant procedures and regulatory standards.

• Handle multiple priorities and promptly communicate any potential risks or delays.

• Assist with other US regulatory consulting tasks as business needs evolve.

⛳️ Requirements

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

• At least five years of experience in regulatory affairs, regulatory operations, labeling, pharmaceuticals, biologics, vaccines, or a related area.

• Proven experience in supporting regulatory submissions, labeling, lifecycle management, or regulatory operations.

• Experience collaborating with cross-functional teams within a regulated setting.

• Strong skills in documentation, organization, communication, and problem-solving.

• Ability to handle multiple assignments and work autonomously.

• Preferred certification in clinical research or regulatory affairs.

• Preferred certification in data analytics or tools for scientific data interpretation.

🏝️ Benefits

• Medical, dental, and vision care.

• Backup dependent care.

• Adoption assistance.

• Infertility coverage.

• Support for family building.

• Behavioral health solutions.

• Paid parental leave.

• Paid caregiver leave.

• Training programs.

• Resources for professional development.

• Mentorship programs.

• Employee resource groups.

• Opportunities for volunteer activities.