A growing CRO seeks a Fractional Regulatory Director to provide strategic FDA regulatory leadership across CDER, CBER, and CDRH, with a focus on ophthalmology, on a flexible part-time basis.
Hartmann Young is partnering with a growing contract research organisation to place a Fractional Regulatory Director on a 10-hour-per-week engagement. The successful candidate will provide strategic regulatory leadership, guiding programs from early development through to commercialisation, leading FDA interactions, and overseeing submissions across CDER, CBER, and CDRH divisions. A background in ophthalmology is essential.
The role combines high-level strategic oversight with hands-on execution, requiring strong cross-functional collaboration with internal teams and clients. Candidates with international regulatory experience covering markets such as Europe, the UK, Latin America, Japan, and APAC are particularly well regarded.
- Lead FDA interactions and manage regulatory submissions across CDER, CBER, and CDRH
- Develop and execute regulatory strategies from early-stage development through commercialisation
- Provide strategic guidance on ophthalmology regulatory pathways and requirements
- Collaborate cross-functionally with internal teams and external clients to align regulatory plans
- Manage stakeholder relationships and communicate regulatory risks and milestones clearly
- Support the development of global regulatory strategies across multiple international markets
- Extensive regulatory affairs experience specifically within ophthalmology
- Proven track record of FDA submissions and direct agency interactions across CDER, CBER, and CDRH
- Demonstrated ability to balance strategic leadership with hands-on regulatory execution
- Experience supporting product programs from early development through to commercialisation
- Strong stakeholder management and cross-functional leadership capability
- International regulatory experience across markets such as Europe, UK, Japan, or APAC is desirable
Hartmann Young is a specialist recruitment and advisory firm partnering with life sciences and healthcare organisations to place senior regulatory, clinical, and scientific professionals. The firm works with a range of CROs, biotechs, and medtech companies across global markets.
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