Regulatory Affairs ConsultantUS | Hybrid & Flexible WorkingWe 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
- Fluent in English.
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.
