Regulatory Affairs Consultant

DLRC Regulatory Consultancy; Boston (MA); Hybrid; USD 120,000 - 190,000; Full time

Benefits offered by this job

Flexible working

Professional development

Collaborative culture

Job summary

DLRC Regulatory Consultancy seeks an experienced Regulatory Affairs Consultant to independently lead regulatory projects across the US, EU and UK regulatory landscapes. You will develop and execute regulatory strategies, manage timelines and build strong client relationships with minimal supervision.

Ideal candidates have strong US regulatory development experience, including pre-IND strategy and FDA meeting interactions, and can mentor junior colleagues while contributing to business

Qualifications

• Regulatory affairs professional with US focus.
• Lead regulatory projects end-to-end.
• Prepare NDA/IND submissions.
• Engage with FDA and stakeholders.
• Mentor junior colleagues.

Responsibilities

• Independently advise clients on regulatory development strategies and applicable regulations.
• Lead the development and delivery of regulatory strategies for allocated projects.
• Lead and support pre-IND activities and FDA meeting interactions.
• Prepare, review and oversee INDs and amendments; NDA/BLAs experience advantageous.
• Manage project timelines, budgets and risks; build client relationships.

Skills

Regulatory affairs

FDA regulations

pre-IND strategy

IND submissions

Project management

Client relationships

US Agent responsibilities

Education

Life Sciences degree

Pharmacy degree

Tools

Microsoft Office

Job 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 Affairs Consultant

US | Hybrid & Flexible Working

We are seeking an experienced Regulatory Consultant, ideally based on the US East Coast/Boston area, 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 particularly suited to a regulatory professional with strong US regulatory development experience, including pre-IND strategy, FDA meeting interactions and INDs, who can take ownership of projects, develop and execute regulatory strategies, and build strong client relationships with minimal supervision.

The opportunity:

You will lead smaller regulatory projects end‑to‑end and act as a subject matter expert on larger programmes, providing strategic regulatory advice and preparing compliant submissions across a range of procedures. You will have a particular focus on US regulatory development, supporting clients through FDA interactions and key development milestones.

As a trusted advisor, you will manage project timelines, resources and risks, while building strong client relationships and contributing to business development, marketing activities and the development of junior colleagues.

Key responsibilities:

• Independently advise clients on applicable regulations, guidance and regulatory development strategies
• Lead the development and delivery of regulatory and SME strategies for allocated projects
• Lead and support pre-IND activities and FDA meeting interactions, including preparation of meeting packages and briefing materials
• Prepare, review and oversee INDs and amendments, with additional experience of NDAs and/or BLAs advantageous
• Support FDA interactions including Type A, B and C meetings, pre-IND and End‑of‑Phase meetings
• Support applications and regulatory strategies relating to Orphan Drug Designation and Paediatric Study Plans (PSPs), where required
• Act as US Agent, where appropriate, supporting communications and interactions with the FDA
• Analyse complex datasets and legislative changes to inform regulatory strategy
• Lead smaller projects independently or act as an SME on larger programmes with minimal supervision
• Manage scope of work, budgets, billing and change orders where required
• Forecast resource requirements and plan workloads to meet project timelines
• Proactively identify regulatory and delivery risks and implement appropriate mitigation strategies
• Develop and maintain strong client relationships, communicating 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 regulatory affairs experience, with a strong focus on US regulatory development
• Demonstrable experience of pre-IND strategy, FDA meeting interactions and IND preparation/submission
• Strong understanding of FDA regulatory requirements and procedures
• NDA experience would be highly desirable
• Experience acting as a US Agent or supporting US Agent responsibilities
• Experience of paediatric regulatory strategy and/or Orphan Drug Designation would be advantageous
• Proven ability to lead regulatory projects and provide strategic advice with minimal supervision
• Strong project management skills, including managing timelines, resources, scope, budgets and risks
• Excellent client relationship and stakeholder management skills, with the confidence to act as a trusted regulatory advisor
• Good working knowledge of the EU and/or UK regulatory environment would be advantageous
• Ability to interpret complex scientific data and evolving regulatory requirements
• Strong commercial awareness with the ability to identify business development opportunities
• Excellent communication and negotiation skills
• Degree in Life Sciences, Pharmacy or equivalent
• Proficient in Microsoft Office applications
• Qualified to work in the 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.