Senior Regulatory Consultant - GRL

Ready to shape global regulatory strategy for innovative oncology and biotechnology products while driving successful lifecycle management across international markets?

Proclinical is seeking a Senior Regulatory Consultant to provide strategic and operational regulatory support for a portfolio of marketed and late-stage oncology and biotechnology products. This role involves both European and global regulatory responsibilities, focusing on lifecycle management activities and serving 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.

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.