Remote Senior Regulatory Science Specialist

AmerisourceBergen Corporation; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Cencora is seeking a Senior Specialist, Regulatory Science to support US regulatory activities across pharmaceutical and biologic programs. This role involves hands-on support for submissions, labeling, lifecycle management, regulatory operations, product stewardship, and compliance, collaborating with internal teams and client stakeholders.

The ideal candidate brings strong regulatory knowledge, exceptional attention to detail, and the ability to manage multiple priorities in a dynamic

Qualifications

• Strong regulatory knowledge and attention to detail.
• Ability to manage multiple priorities in a dynamic consulting environment.
• Hands-on support across regulatory submissions, labeling, lifecycle management, and compliance activities.

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, 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.
• Collaborate cross-functionally with Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, Commercial, and other stakeholders as needed.
• Support onboarding, training, knowledge transfer, and regulatory systems activities.
• Ensure assigned deliverables comply with applicable procedures, client expectations, and US regulatory requirements.
• Manage multiple priorities simultaneously and communicate risks, issues, or delays in a timely manner.
• Support broader US regulatory consulting activities as business and client needs evolve.

Job description

Cencora is seeking a Senior Specialist, Regulatory Science to support US regulatory activities across pharmaceutical and biologic programs. This role involves hands-on support for submissions, labeling, lifecycle management, regulatory operations, product stewardship, and compliance, collaborating with internal teams and client stakeholders.

The ideal candidate brings strong regulatory knowledge, exceptional attention to detail, and the ability to manage multiple priorities in a dynamic