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.
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Senior Regulatory Consultant - GRL in Maidenhead employer: ProClinical
Join a globally recognised biopharmaceutical organisation that prioritises innovation and collaboration in the field of protein science and biologic drug development. With a strong commitment to employee growth, you will have access to continuous learning opportunities and be part of a supportive team dedicated to delivering life-changing therapies. Located in a vibrant area, this role not only offers meaningful work but also a dynamic work culture that values your contributions and fosters professional development.
