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Regulatory affairs consultant- uk/germany based

Letchworth Garden City
DLRC Regulatory Consultancy
Consultant
Posted: 25 February
Offer description

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.

Regulatory Consultant - Permanent Opportunity

UK or Germany | Hybrid & Flexible Working

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
You will lead smaller regulatory engagements end-to-end, develop and deliver regulatory strategies, and prepare compliant submissions across multiple procedures. Acting as a trusted advisor to clients, you'll manage 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 or Germany; fluent in English.

Why join us?
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.

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