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.

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Preferred Qualifications / Experience

• 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

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Affiliated Companies: Cencora Global Consulting Services US Corporation