Senior Manager Regulatory Affairs (ATMP / Gene therapy; Analytical; US and EU CMC regulatory)

Our 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

This job profile description is a standardized, non-contractual reference description and global reference tool provided for organizational consistency and talent architecture purposes across Cencora. It does not alter actual job duties, responsibilities, reporting lines, working conditions, grading, compensation, or other essential terms and conditions of employment.

Actual duties and responsibilities may vary based on business needs, local requirements, and operational practices. Where a team member's role is governed by an employment agreement, local terms and conditions, prior job description or collective bargaining agreement, those documents shall prevail in case of any inconsistency. Mandatory local laws shall also prevail.

Delivers client engagements and work products related to pharmacovigilance, safety surveillance, risk management, and related scientific consulting services within defined scope, quality, and timeline expectations.

Coordinates case processing, documentation, reporting activities, and operational handoffs to support accurate, timely, and compliant safety deliverables.

Analyzes safety data, literature, and other relevant information to support signal detection, signal assessment, and fit-for-purpose client recommendations.

Supports development and maintenance of risk management deliverables, benefit-risk assessments, and related regulatory documentation across the product lifecycle.

Recommends and implements improvements to procedures, templates, and workflow controls that improve quality, reduce rework, and strengthen compliance within the job area.

Facilitates coordination with client stakeholders and internal partners to confirm requirements, resolve routine issues, and maintain alignment to service expectations and controls.

Guides less-experienced professionals through practical application of standards, documentation expectations, and reusable ways of working.

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Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required.

4+ years of experience in Analytical/ Cell & Gene Therapy Regulatory Affairs.

Mandatory technical experience in ATMP / Gene therapy; Analytical; US and EU CMC regulatory

Certification in pharmacovigilance, drug safety preferred. Certification in regulatory affairs, clinical safety preferred. Certification in quality management, auditing preferred.

What Cencora offers

​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies: PharmaLex Spain S.L.U.

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