Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management.
Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management.
Act as Regulatory Integral Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand-alone projects
Lead the preparation, review, and submission of regulatory documentation, ensuring high quality and compliance with applicable regulations and guidelines
Manage project timelines, deliverables, budgets, and out-of-scope activities to ensure successful project execution and financial performance




Mentor and provide guidance to junior colleagues, including review of regulatory documentation and support for training and professional development
Support business development activities, including travelling to and participating in bid defense meetings and client presentations
Support global, regional, and cross-functional regulatory initiatives and process improvement activities
Perform additional duties as assigned to support business and departmental objectives
Bachelor's Degree in Life Sciences or a related discipline required
Master's Degree in Life Sciences or a related discipline preferred
Minimum of 8 years of regulatory affairs experience within the pharmaceutical, biotechnology, CRO, or related industry
Proven experience advising clients on EU regulatory strategy, including RMS selection, submission planning, and scientific advice strategy
Strong understanding of regulatory documentation requirements across d

📌 Compliance Manager/Senior Manager (Alcobendas)
🏢 Cencora
📍 Alcobendas