Regulatory Affairs Consultant

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

US | Hybrid & Flexible Working

We are seeking an experienced Regulatory Consultant to independently lead regulatory projects and deliver high-quality, pragmatic regulatory advice to clients across the US, EU, and UK regulatory landscapes.

This role is well suited to a confident regulatory professional who can take ownership of projects, develop and execute regulatory strategies, and manage client relationships with minimal supervision, while contributing to the growth and capability of a collaborative consultancy.

The opportunity

You will lead smaller regulatory projects end-to-end and act as a subject matter expert on larger programmes, providing strategic advice and preparing compliant submissions across a range of procedures. As a trusted advisor, you will manage timelines, resources, and risks, while also supporting business development initiatives, marketing activities, and mentoring junior colleagues.

Key responsibilities:

· Independently advise clients on applicable regulations and guidance

· Lead the development and delivery of regulatory and SME strategies for allocated projects

· Prepare, review, and oversee US regulatory submissions, including INDs and amendments, NDAs and BLAs, meeting packages for FDA interaction, Orphan Drug, Fast Track, Breakthrough Therapy, and PSPs

· Lead smaller projects independently or act as an SME with minimal supervision

· Manage scope of work, budgets, billing, and initiate change orders where required

· Forecast resource requirements and plan workloads to meet project timelines

· Proactively identify regulatory and delivery risks and implement mitigation strategies

· Communicate effectively with clients and regulatory authorities

· Identify and feedback new business opportunities to Project Leads and Business Development teams

· Support and participate in marketing activities and networking events

· Mentor junior team members and contribute to their professional development

· Promote company values and foster a positive, collaborative culture

· Ensure delivery in line with DLRC Quality Management requirements.

About you:

· Significant experience in regulatory affairs, including leading projects and providing strategic regulatory advice

· Proven ability to prepare and manage complex regulatory submissions and agency interactions

· Strong understanding of US regulatory procedures and a good working knowledge of the EU regulatory environment

· Experience interpreting complex datasets and evaluating evolving regulatory landscapes

· Demonstrated capability in project management, resource planning, and risk mitigation

· Strong commercial awareness with the ability to identify and act on business development opportunities

· Excellent communication and negotiation skills, with the ability to clearly explain complex scientific and regulatory issues

· Degree in Life Sciences, Pharmacy, or equivalent

· Proficient in Microsoft Office applications

· Qualified to work in the US

· 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.