VP Technical – Clinical Development Regulatory Consulting
VP Technical – Clinical Development Regulatory Consulting
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Established in 2005, DLRC Ltd has developed a deserved reputation for being a leading consultancy, with a wealth of regulatory and scientific knowledge and considerable experience in both leadership and management. The company has recently expanded to include affiliates based in Germany and the US.
Our growing team comprises over 90 qualified professionals with a pharmaceutical and/or regulatory background, as well as over 30 dedicated supporting staff in areas of Business Development, Finance, Business Services and People Practices. We provide services to over 130 organisations, enabling them to achieve their strategic and operational development objectives.
DLRC’s expertise and flexible working approach ensures the provision of a highly motivated team who interact effectively with clients and regulators globally, to support both single issues and long-term commitment to projects.
We are looking to expand our Technical Regulatory team and are currently looking for a Vice President (VP) Technical – Clinical Development Regulatory Consulting to join us on a permanent basis.
This position can be worked on hybrid basis or from our offices in Letchworth, UK.
The role
The Vice President – Regulatory Affairs (Technical) is a senior strategic expert responsible for supporting complex, high-value regulatory programs across global clinical development and lifecycle management. This role includes technical oversight of submissions, regulatory strategy leadership, and expert-level client engagement. The Vice President will also drive innovation in regulatory consulting services, develop internal talent, and support DLRC’s strategic growth ambitions.
With respect to Clinical Development, the Vice President Technical will lead support for strategic clinical development consulting projects for our global biopharmaceutical and biotech clients. They will serve as a key thought leader, providing expert guidance on clinical regulatory strategy, global development pathways, and agency interactions across all stages of clinical development.
Responsibilities:
· Provide expert technical input high-profile regulatory projects, including clinical global development strategy, IND/CTA development, clinical trial applications, marketing authorisation submissions (MAAs, NDAs, BLAs), and post-approval lifecycle management
· Provide direct expert advice and strategic oversight for regulatory agency interactions at both national (MHRA, FDA) and EU (EMA) levels
· Develop and defend complex regulatory strategies, including accelerated approval, PRIME, breakthrough, PIP, and orphan drug pathways
· Analyse evolving global regulatory frameworks and their impact on client programs and internal methodologies
· Develop regulatory roadmaps and ensure strategic alignment with clients' development, commercial, and investment milestones
· Guide and oversee scientific advice preparation, pre-submission meetings, and critical health authority engagement
· Execute and monitor strategic regulatory plans to meet both project-specific and client portfolio goals
· Represent DLRC in regulatory forums, industry roundtables, and key opinion leader engagements.
Required Experience:
· Advanced degree in Life Sciences, Pharmacy, Medicine, or a related discipline (PhD, PharmD, MSc preferred)
· Right to work in the UK
· Fluent in English
· Extensive industry experience in EU and global regulatory affairs, with demonstrable leadership and strategic delivery
· Strong consulting and/or industry track record in advanced therapy, biologics, oncology, or other high-complexity areas is highly desirable.
Seniority level
* Seniority level
Executive
Employment type
* Employment type
Full-time
Job function
* Job function
Strategy/Planning, Research, and Science
* Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Business Consulting and Services
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