Senior Specialist – Regulatory Science

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

📋 Description

• Assist with US regulatory activities for pharmaceutical and biologic products across various programs and clients.

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

• Aid in the development, review, approval, implementation, and maintenance of labeling.

• Sustain regulatory documentation, correspondence, submission trackers, and product information.

• Assist with regulatory operations, document workflows, submission tracking, and records management.

• Contribute to lifecycle management and product stewardship efforts throughout the product lifecycle.

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

• Collaborate with Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, Commercial, and other stakeholders.

• Facilitate onboarding, training, knowledge transfer, and regulatory systems initiatives.

• Ensure that deliverables meet procedures, client expectations, and US regulatory standards.

• Manage multiple priorities and communicate risks, issues, or delays promptly.

• Support broader US regulatory consulting initiatives as business and client requirements change.

⛳️ Requirements

• Experience in supporting US regulatory activities for pharmaceutical and/or biologic products.

• Familiarity with regulatory submissions, labeling, lifecycle management, and regulatory operations.

• Strong organizational abilities to manage multiple projects and deadlines effectively.

• Excellent communication and stakeholder management capabilities.

• Experience in a consulting, client-facing, or cross-functional environment is advantageous.

• Animal Health regulatory experience is preferred but not mandatory.

🏝️ Benefits

• Medical, dental, and vision care.

• 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.

• Reasonable accommodations during the employment process.