Regulatory Manager / Senior Regulatory Manager

Overview

As Regulatory Manager, you guide regulatory strategy across the clinical development lifecycle to enable efficient trials and timely regulatory submissions. You will coordinate documents for authorities and ethics committees, and represent Global Regulatory Affairs in project teams. The role blends strategic input, cross-functional collaboration, and leadership to ensure compliant, high-quality submissions. This is a globally oriented position within a high-growth organization focused on oncology and rare diseases.

Responsibilities

• Provide regulatory guidance throughout the clinical development life cycle
• Prepare and coordinate regulatory submissions to Authorities and Ethics Committees (CTA/IND, annual reports, amendments, scientific advice, orphan designations, paediatric planning, etc.)
• Develop/review submission documents to ensure regulatory compliance
• Represent Global Regulatory Affairs in project teams and interact with external/internal stakeholders
• Lead/regulate Regulatory Affairs Specialists to meet submission targets
• Maintain project plans, trackers, and regulatory intelligence tools
• Contribute to regulatory strategy and timeline development for new study opportunities
• Support corporate quality initiatives and maintain ICH GCP guidance to clients

Key requirements

• Bachelor degree or equivalent in scientific/healthcare field
• 5 years regulatory experience for Manager level; 7 years for Senior Manager level
• Experience with CRO or pharmaceutical industry and leading clinical submissions
• Ability to interpret clinical/pre-clinical results for regulatory strategy
• Knowledge of regulatory activities for EU/US regions (IND/CTA submissions, scientific advice, post-approval submissions)
• Willingness to travel domestically and internationally
• Strong interpersonal skills and ability to work in cross-functional teams
• Proven ability to manage multiple tasks in a fast-moving environment
• Professionalism, reliability, and customer-focused mindset
• Excellent written and spoken English communication skills

• strong interpersonal skills
• team collaboration
• self-motivation
• regulatory strategy and submissions (IND/CTA, amendments, orphan designations)
• regulatory intelligence and compliance
• ICH GCP guidance understanding

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