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

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

Cencora

Madrid, Spain

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.

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.