Senior Regulatory Affairs Consultant

ROLE OVERVIEW An exciting opportunity for a Regulatory Affairs Lead – Gene Therapy to join our client within the advanced therapies sector, leading regulatory strategy and delivery for a new Marketing Authorisation submission to both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).This full-time opportunity is planned to commence at the start of January 2027 and will involve close collaboration with Research and Development (R&D), Chemistry, Manufacturing and Controls (CMC), regulatory affairs and senior leadership teams.

The successful candidate will bring gene therapy expertise to regulatory strategy, health authority engagement and global submission planning.

KEY DUTIES AND RESPONSIBILITIES Your duties as the Regulatory Affairs Lead – Gene Therapy will be varied however the key duties and responsibilities are as follows:

Lead the regulatory strategy and delivery for a new Marketing Authorisation submission to the EMA and FDA.Plan and manage pre-submission applications, health authority engagement and associated regulatory interactions.

Work closely with R&D and CMC teams to coordinate submission content and ensure regulatory alignment.

Generate the EU Module 1 and coordinate dossier authoring, submission management and publishing activities across the EU and US.As the Regulatory Affairs Lead you will coordinate local US regulatory affairs activities and escalate key matters to the Vice President of Regulatory Affairs.

ROLE REQUIREMENTS To be successful in your application to this exciting role as the Regulatory Affairs Lead – Gene Therapy we are looking to identify the following on your profile and past history:

A Degree or higher level in a relevant scientific, pharmaceutical, regulatory affairs or related field.

Proven regulatory affairs experience supporting Marketing Authorisation submissions to the EMA and FDA, including pre-submission engagement and dossier coordination.

Gene therapy expertise, with the ability to contribute effectively to regulatory strategy and health authority interactions.

Experience coordinating EU Module 1, submission management, publishing and US regulatory affairs activities; knowledge of conditional approval and orphan designation would be beneficial.

WHAT’S IN IT FOR YOU?

The opportunity to lead regulatory strategy for a significant new EU and US submission within the advanced therapies sector.

A highly collaborative position working across R&D, CMC, regulatory affairs and senior leadership teams.

The chance to contribute specialist gene therapy expertise to health authority engagement and global regulatory planning.

A full-time opportunity planned to commence at the start of January 2027.Key Words:
Regulatory Affairs Lead / Gene Therapy / Marketing Authorisation / EMA / FDA / Regulatory Strategy / Health Authority Engagement / EU Module 1 / Dossier Authoring / Submission Management / CMC / R&D / Orphan Designation / Conditional Approval"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career"