Senior Specialist- Regulatory Science

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

## Senior Specialist- Regulatory ScienceApply: Remote, USA: Full time: Posted Today: R2612670Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# **Job Details**The **Senior Specialist , Regulatory Science** supports US regulatory activities across pharmaceutical and biologic programs for a range of client needs. This role provides hands-on support across regulatory submissions, labeling, lifecycle management, regulatory operations, product stewardship, and compliance activities. The position works closely with internal teams and client stakeholders to help ensure regulatory activities are executed accurately, compliantly, and within required timelines. The ideal candidate brings strong regulatory knowledge, attention to detail, and the ability to manage multiple priorities in a dynamic consulting environment. **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 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.