Senior Specialist – Regulatory Science
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Job Description
Senior Regulatory Science Specialist supporting US pharmaceutical and biologic submissions, labeling, and lifecycle management at Cencora. Coordinating compliant regulatory activities for clients and cross-functional teams.
Responsibilities:
- Support US regulatory activities for pharmaceutical and biologic products across multiple programs and clients
- Prepare, coordinate, and support regulatory submissions, registrations, annual reports, and post-approval changes
- Support labeling development, review, approval, implementation, and maintenance activities
- Maintain regulatory documentation, correspondence, submission trackers, and product information
- Support regulatory operations, document workflows, submission tracking, and records management
- Contribute to lifecycle management and product stewardship activities across the product lifecycle
- Evaluate product, labeling, manufacturing, and quality changes for potential regulatory impact
- Collaborate with Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, Commercial, and other stakeholders
- Support onboarding, training, knowledge transfer, and regulatory systems activities
- Ensure deliverables comply with procedures, client expectations, and US regulatory requirements
- Manage multiple priorities and communicate risks, issues, or delays in a timely manner
- Support broader US regulatory consulting activities as business and client needs evolve
Requirements:
- Experience supporting US regulatory activities for pharmaceutical and/or biologic products
- Familiarity with regulatory submissions, labeling, lifecycle management, and regulatory operations
- Strong organizational skills with the ability to manage multiple projects and deadlines
- Effective communication and stakeholder management skills
- Experience working in a consulting, client-facing, or cross-functional environment is a plus
- Animal Health regulatory experience is desirable, but not required
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
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