Senior Regulatory Specialist – US Submissions & Lifecycle

myhrabc; United States; On-site; USD 52,000 - 82,000; Full time

Job summary

Cencora seeks a Senior Specialist, Regulatory Science to support US regulatory activities across pharmaceutical and biologic programs for diverse client needs. You will provide hands‑on support for submissions, labeling, lifecycle management, regulatory operations, and product stewardship, working with internal teams and client stakeholders to meet timelines.

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

Qualifications

• 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.

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.

Job description

Cencora seeks a Senior Specialist, Regulatory Science to support US regulatory activities across pharmaceutical and biologic programs for diverse client needs. You will provide hands‑on support for submissions, labeling, lifecycle management, regulatory operations, and product stewardship, working with internal teams and client stakeholders to meet timelines.

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