Senior Regulatory Consultant - GRL

Strategic Regulatory Leadership for Global Oncology and Biotechnology

Shape global regulatory strategy for innovative oncology and biotechnology products while driving successful lifecycle management across international markets. This role provides strategic and operational regulatory support for a portfolio of marketed and late-stage products, involving both European and global responsibilities. As a key member of cross-functional regulatory teams, you will play a pivotal role in developing and executing regulatory strategies while ensuring compliance with global and regional requirements.

Core Responsibilities

• Act as a member of EU and Global Regulatory Teams for assigned commercial programs.
• Develop and execute global regulatory strategies for post-approval products.
• Provide strategic regulatory guidance to cross-functional teams and stakeholders.
• Review and approve regulatory documents and submissions for global markets.
• Support regional regulatory teams, ensuring alignment with global objectives.
• Participate in Health Authority interaction planning and address regulatory queries.
• Represent Regulatory Affairs within multidisciplinary product teams.
• Contribute regulatory insights during quarterly safety review meetings and benefit-risk discussions.
• Identify regulatory risks, challenges, and opportunities, proposing actionable solutions.
• Lead EU lifecycle management activities, including variation submissions and regulatory procedures.
• Oversee labelling updates and implementation across European markets.
• Prepare and coordinate Periodic Safety Update Reports (PSURs) and renewal submissions.
• Maintain Marketing Authorisations and ensure ongoing regulatory compliance.
• Manage regulatory aspects of clinical trial activities, including substantial amendments.
• Provide guidance on emerging EU regulatory requirements and their impact on product strategy.

Key Skills and Requirements

• Extensive experience in Regulatory Affairs within the biotechnology or pharmaceutical industry.
• Proven expertise as a Global Regulatory Lead or in global regulatory strategy for innovative products.
• Strong knowledge of EU and global regulatory frameworks.
• Significant experience in post-approval lifecycle management and supporting marketed products.
• Proficiency in European regulatory procedures, including variations, renewals, labelling updates, and PSURs.
• Ability to assess complex regulatory challenges and develop practical, strategic solutions.
• Experience reviewing and approving regulatory documentation for international markets.
• Excellent communication, negotiation, and stakeholder management skills.

Preferred Skills and Experience

• Experience transitioning products from development to commercialisation.
• Familiarity with rare disease, specialty pharmaceutical, or biotech products.
• Experience working in global matrixed organisations.
• Exposure to both regional and global regulatory leadership responsibilities.
• Ability to manage multiple products in a fast-paced environment.