Regulatory Affairs Professional

1 week ago

London, Greater London, United Kingdom Orchard Therapeutics Full time

We are seeking a highly skilled Regulatory Affairs Professional to join our team at Orchard Therapeutics.

As a key member of our regulatory affairs team, you will be responsible for supporting the development and implementation of global regulatory strategies for early-stage ex vivo gene therapy programs. You will work closely with our Global and Regional Regulatory Leads to ensure timely and effective submissions to regulatory authorities in the EU, UK, and US.

This role offers opportunities for growth and personal development in a dynamic and innovative environment.

Key Responsibilities

  • Support the development of global regulatory strategies for early-stage ex vivo gene therapy programs aligned with program goals, enabling timely pivotal study initiation and expedited approval paths.
  • Prepare and/or review regulatory documentation to support global clinical trials setup and maintenance in compliance with company and applicable regulations.
  • Partner with regional Regulatory Leads to support liaison with academic partners and clinical research organizations (CROs) and coordinate CTA regulatory activities.
  • Contribute to GCP readiness activities and prepare/review regulatory documentation to support Orphan Drug Designations (ODD), Paediatric Investigation Plans (PIP), and necessary Agency meetings in the EU, UK, or US.
  • Provide proactive support to EU/UK Regulatory Leads for timely submissions, coordination, and preparation of responses to regulatory authority questions according to the regulatory plan.
  • Collaborate with the US Regulatory Lead on preparing US regulatory submissions such as ODDs, meeting requests, or briefing packages.
  • Maintain and improve team standard operating procedures (SOPs) by editing existing SOPs or supporting new authoring as relevant.
  • Monitor, analyze, and disseminate relevant regulatory intelligence.

Requirements

Required Experience / Knowledge

  • An early regulatory career professional with experience in EU/UK regulatory affairs for Phase 1-3 development programs within industry, CRO, or regulatory consultancies.
  • Proven experience in preparing and submitting regulatory documentation to support clinical trial applications and amendments in the EU and UK.
  • Knowledge of the global clinical trials landscape and ability to interpret country requirements and processes for clinical trial authorization.
  • Familiarity with ICH and EU/UK regulatory guidelines, including the EU Clinical Trials Regulation and the UK Combined Review.
  • Good understanding of EMA and FDA requirements for pre-authorisation regulatory activities.

Education

  • BSc degree or equivalent in life sciences; an advanced degree is highly desirable.
  • Regulatory Affairs certification is a plus.

Skills and Abilities

  • Able to work in a cross-functional team environment.
  • Strong collaboration mindset and excellent organizational skills.
  • Excellent verbal and written communication skills.

Estimated Salary: $120,000 - $150,000 per annum

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