The Senior Regulatory Affairs Specialist supports US regulatory activities for Animal Health pharmaceutical and biological products. The role provides hands-on support across product labeling, regulatory operations, lifecycle management, regulatory submissions, product stewardship, and compliance activities.

The position works closely with internal and client stakeholders to ensure regulatory activities are completed accurately, compliantly, and within required timelines.

Responsibilities:

• Support US labeling activities for Animal Health pharmaceutical and biological products.
• Coordinate labeling development, review, approval, implementation, and maintenance.
• Prepare and coordinate regulatory submissions, registrations, annual reports, and postapproval changes.
• Support regulatory operations, document workflows, submission tracking, and records management.
• Maintain regulatory documentation, correspondence, trackers, and product information.
• Support lifecycle management and product stewardship activities.
• Evaluate product, labeling, manufacturing, and quality changes for potential regulatory impact.
• Collaborate with Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, and Commercial teams.
• Support onboarding, training, knowledge transfer, and regulatory-system activities.
• Ensure assigned deliverables comply with applicable procedures and regulatory requirements.
• Manage multiple priorities and communicate potential risks or delays promptly.
• Support other US regulatory consulting activities as business needs evolve.

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Education:

• Bachelor’s degree in a scientific, regulatory, pharmaceutical, or related discipline.
• Certification in clinical research or regulatory affairs preferred. Certification in data analytics or scientific data interpretation tools preferred.

Experience:

• Five or more years of regulatory affairs, regulatory operations, labeling, pharmaceutical, biologics, vaccines, or related experience.
• Experience supporting regulatory submissions, labeling, lifecycle management, or regulatory operations.
• Experience working with cross-functional teams in a regulated environment.

Skills:

• Strong documentation, organization, communication, and problem-solving skills.
• Ability to manage multiple assignments and work independently.

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 [email protected]. 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