Contract Opportunities

Regulatory Lead – Rare Disease/Advanced Therapies

Contract: 6 months

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We are seeking an experienced Global Regulatory Lead (GRL) for an initial 6-month contract to provide maternity cover within a growing rare disease/advanced therapies portfolio.

The role will support regulatory strategy and execution across FDA and European markets, with a particular focus on siRNA-based therapies. Experience in rare disease, gene therapy, neurology or pulmonary development would be highly desirable, but is not essential.

The Role

Lead global regulatory activities across FDA and EU markets, including regulatory strategy, submissions and agency interactions.
Support a Phase 3 programme, where the regulatory briefing package is substantially complete and requires finalisation, submission and management of subsequent agency feedback/updates.
Support a Phase 1 programme, including preparation and updates to the IMPD, IND refiling and associated regulatory activities.
Manage EU CTR, FDA IND and global regulatory amendments throughout the programmes.
Work cross-functionally with clinical, CMC, nonclinical and other development teams to ensure regulatory deliverables are aligned and submission-ready.
Provide strategic input on accelerated regulatory pathways and novel delivery mechanisms.
Support ongoing interactions with regulatory authorities and ensure commitments and emerging requirements are appropriately managed.

Requirements

Strong experience as a Global Regulatory Lead / Regulatory Affairs Lead in drug development.
Experience with FDA and EU regulatory submissions and interactions.
Knowledge of accelerated development pathways, innovative modalities and/or novel drug delivery technologies.
Experience with siRNA or other advanced modalities would be advantageous.
Rare disease, gene therapy, neurology or pulmonary experience is desirable but not essential.
Able to operate independently and hit the ground running in a short-term, delivery-focused contract.

Timing: Immediate start preferred.

Duration: Approximately 6 months.

Working model: Fully remote, with availability aligned to US Eastern Time.