Senior Regulatory Affairs Consultant

We are recruiting a Senior Regulatory Affairs Consultant to join a leading Pharmaceutical company on a fully remote basis. As the Senior Regulatory Affairs Consultant you will support our client’s gene therapy marketing authorisation submissions to the EMA and the US FDA.

We expect this role to require 140 hours per month, is outside IR35 and for an initial 12 months, starting early January 2027.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Regulatory Affairs Consultant will be varied however the key duties and responsibilities are as follows:

1. As the Senior Regulatory Affairs Consultant, you will lead regulatory strategy and delivery for new marketing authorisation (MAA) submissions in Europe and the US, including pre-submission applications and health authority engagement. You will apply gene therapy expertise to regulatory positioning, anticipate questions and help establish a clear route towards submission.

2. As the Senior Regulatory Affairs Consultant you will work closely with R&D and CMC colleagues to align scientific content with the regulatory strategy. You will identify evidence gaps, resolve cross-functional dependencies and maintain a clear view of submission readiness.

3. As the Senior Regulatory Affairs Consultant you will generate an EU Module 1 and coordinate dossier authoring for European and US submissions. You will guide contributors on content expectations, review documentation for consistency and help ensure that the dossier presents a coherent scientific and regulatory case.

4. As the Senior Regulatory Affairs Consultant Coordinate submission management, publishing activities and local US regulatory affairs support. You will track milestones, highlight delivery risks and escalate issues requiring senior input to the VP of Regulatory Affairs.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Consultant we are looking to identify the following on your profile and past

History

1. Relevant understanding underpinning gene therapy development and regulatory submissions, comprehensive practical industry experience is essential.

2. Demonstrable gene therapy regulatory affairs expertise, with relevant experience of European and US submission strategy, dossier delivery and health authority engagement. Experience with conditional approval pathways and orphan designation would be beneficial.

3. A working knowledge and practical experience with regulatory dossier preparation, European Module 1 content and cross-functional authoring coordination, alongside the ability to manage submission dependencies and communicate regulatory risks clearly.

Key Words: Senior Regulatory Affairs Consultant / Gene Therapy / Regulatory Strategy / Marketing Authorisation / European Medicines Agency / Food and Drug Administration / Module 1 / Regulatory Submissions / Orphan Designation / Conditional Approval / CGT / Cell and Gene Therapy / Biopharma / RA / Regulatory Affairs / Regulatory Affairs Contractor / FDA / EMA / MAA / MA / Marketing Authorisation / Marketing Authorisations

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.