Regulatory Affairs Consultant in Letchworth Garden City

Established in 2005, the DLRC Group 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 seeking a Regulatory Consultant to independently lead regulatory projects and deliver high-quality, pragmatic advice to clients across UK, EU, and US regulatory environments. This role is ideal for an experienced regulatory professional who is confident owning projects, developing regulatory strategy for defined programmes, and managing client relationships with minimal supervision — while continuing to grow within a collaborative consultancy.

The opportunity

• Lead smaller regulatory engagements end-to-end, develop and deliver regulatory strategies, and prepare compliant submissions across multiple procedures.
• Act as a trusted advisor to clients, managing timelines, resources, and risk, while contributing to business development and mentoring colleagues.

Key responsibilities:

• Independently advise clients on applicable regulations and guidance.
• Develop and deliver regulatory and SME strategies for defined projects.
• Prepare and manage regulatory submissions including CTAs, MAAs, variations, Scientific Advice, PIPs, and Orphan Drug applications.
• Analyse complex datasets and regulatory changes to inform strategy.
• Lead smaller projects independently or act as an SME with minimal supervision.
• Manage scope, budgets, billing, and change control.
• Forecast resources and plan workload to meet project timelines.
• Communicate directly with clients and regulatory authorities.
• Identify business development opportunities and support marketing and networking activities.
• Mentor junior team members and contribute to capability development.
• Ensure delivery in line with Quality Management requirements and company values.

About you:

• Significant experience in regulatory affairs, including project leadership and strategic advice.
• Proven experience preparing and managing regulatory submissions and agency interactions.
• Strong understanding of national, EU, and US regulatory procedures.
• Confident interpreting complex datasets and evolving regulatory environments.
• Strong project management capability, including resource planning and risk mitigation.
• Commercially aware, with the ability to identify and act on growth opportunities.
• Excellent communicator with sound regulatory and business judgement.
• Degree in Life Sciences, Pharmacy, or equivalent.
• Eligible to work in the UK; fluent in English.

We are a consultancy built on integrity, respect, and accountability. Our people are trusted to take ownership, supported to develop, and encouraged to think commercially. We bring energy and enthusiasm to our work, collaborating closely with clients and partners to deliver practical, sustainable solutions. With flexible working and strong professional development pathways, we offer an environment where regulatory consultants can build influence, capability, and long-term careers.

We review applications and conduct interviews on a rolling basis, so don't delay in applying. Our Talent Acquisition team will be in touch with an update once your application has been reviewed.