Senior Regulatory Consultant / Senior Regulatory Consultantess

Join Our Team as a Senior Regulatory Consultant

Are you 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 encompasses both European and global regulatory responsibilities, with a focus on lifecycle management activities, making you a key member of cross-functional regulatory teams.

Your Impact

In this pivotal role, you will develop and execute regulatory strategies while ensuring compliance with global and regional requirements. You will be instrumental in:

• Acting as a member of EU and Global Regulatory Teams for assigned commercial programs.
• Developing and executing global regulatory strategies for post-approval products.
• Providing strategic regulatory guidance to cross-functional teams and stakeholders.
• Reviewing and approving regulatory documents and submissions for global markets.
• Supporting regional regulatory teams to ensure alignment with global objectives.
• Participating in Health Authority interaction planning and addressing regulatory queries.
• Representing Regulatory Affairs within multidisciplinary product teams.
• Contributing regulatory insights during quarterly safety review meetings and benefit-risk discussions.
• Identifying regulatory risks, challenges, and opportunities, proposing actionable solutions.
• Leading EU lifecycle management activities, including variation submissions and regulatory procedures.
• Overseeing labelling updates and implementation across European markets.
• Preparing and coordinating Periodic Safety Update Reports (PSURs) and renewal submissions.
• Maintaining Marketing Authorisations and ensuring ongoing regulatory compliance.
• Managing regulatory aspects of clinical trial activities, including substantial amendments.
• Providing 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 commercialization.
• Familiarity with rare disease, specialty pharmaceutical, or biotech products.
• Experience working in global matrixed organizations.
• Exposure to both regional and global regulatory leadership responsibilities.
• Ability to manage multiple products in a fast-paced environment.

How to Apply

If you are interested in this exciting opportunity, apply online using the form below. Please note that only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.