Job Overview Individual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. 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.
Job Overview Individual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. 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.
Essential Functions
- 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
- Provide strategic regulatory advice to clients, including EU submission strategy, Reporting Member State (RMS) selection, scientific advice planning, and lifecycle management activities
- Lead and support EU CTR submissions, including initial CTA submissions, substantial modifications, Requests for Information (RFIs), and CTIS lifecycle activities
- Manage communications and interactions with regulatory authorities, including support for and participation in agency meetings.
- Build and maintain strong client relationships, acting as a trusted advisor on regulatory matters and proactively resolving issues
- Manage project timelines, deliverables, budgets, and out-of-scope activities to ensure successful project execution and financial performance
- Mentor and provide guidance to junior collea

📌 Regulatory Affairs Manager (Alcobendas)
🏢 Cencora
📍 Alcobendas