Regulatory Manager / Senior Regulatory Manager

Overview

In this Regulatory role, you guide regulatory strategy across clinical development, submissions, and interactions with authorities to support oncology and rare disease programs. You will coordinate global regulatory documents, lead or support project teams, and ensure timely, compliant submissions. You’ll shape regulatory input for trials, orphan designations, paediatric plans, and accelerated procedures, working closely with cross-functional teams. The opportunity combines scientific insight with regulatory leadership to advance groundbreaking therapies and improve patient outcomes.

Responsibilities

• Provide regulatory guidance throughout the clinical development life cycle
• Coordinate and review regulatory submissions to authorities (CTA/IND, annual reports, amendments, orphan designations, paediatric planning, etc.)
• Develop/review submission documents for regulatory authorities and ethics committees
• Represent Global Regulatory Affairs at project team meetings with internal and external stakeholders
• Lead or participate in regional/global regulatory projects and manage Regulatory Affairs Specialists
• Maintain project plans, trackers, and regulatory intelligence tools; update Regulatory Leadership
• Contribute to regulatory strategy and timeline development for new study opportunities
• Support corporate quality initiatives and establish standards for high-quality submissions
• Provide ICH GCP guidance and training to clients and internal teams
• Represent Regulatory Affairs at business development meetings
• Stay updated on laws, regulations, and guidelines governing drug development

Key requirements

• Bachelor degree or equivalent experience
• 5 years regulatory experience for Manager level; 7 years for Senior Manager level
• Experience with CRO or pharmaceutical industry regulatory submissions and clinical submissions leadership
• Understanding of drug development processes and regulatory milestones (EU/US)
• Experience with INDs/CTAs, scientific advice procedures, and post-approval submissions
• Ability to interpret clinical/pre-clinical results for regulatory strategy
• Knowledge of clinical trials methodology and protocols
• Available for domestic and international travel
• Strong interpersonal skills and ability to work in cross-functional teams
• Professionalism, reliability, and ability to manage multiple tasks in a fast-paced environment
• Proficiency in English (verbal and written)
• Experience presenting to diverse audiences

• Strong interpersonal skills
• Team-oriented with ability to lead projects
• Self-motivated and proactive
• Regulatory submissions (CTA/IND, amendments, orphan designations)
• Regulatory strategy development
• Regulatory intelligence and tracking tools

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