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Director, regulatory affairs, precision medicine & digital health

Stevenage
GSK
Director of regulatory affairs
€80,000 a year
Posted: 16h ago
Offer description

You will lead regulatory strategy for precision medicine and digital health across respective regions. You will work with scientific, clinical, digital and commercial teams to design and deliver regulatory plans that enable safe, effective and compliant development. This role offers visible impact, career growth, and the chance to help unite science, technology and talent to get ahead of disease together.


Key Responsibilities

* Lead development and execution of regional regulatory strategies for precision medicine and digital health assets.
* Coordinate regulatory interactions with local and regional health authorities and external partners.
* Provide regulatory input to cross‑functional project teams from early development through lifecycle management.
* Ensure regulatory compliance for companion diagnostics, software as a medical device (SaMD), and digital health components.
* Interpret regulatory feedback and translate it into clear operational plans and submission materials.
* Mentor and coach colleagues to build regulatory capability across the business.

In addition, you will have opportunities to lead high‑visibility projects and grow your regulatory leadership skills, working with multidisciplinary teams and external partners to shape how new technologies reach patients.


Required Qualifications

* Bachelor's degree in biological science, healthcare science, engineering or an equivalent field.
* Experience working in the pharmaceutical industry, MedTech industry or regulatory authorities.
* Practical experience with regulation of companion diagnostics and/or SaMD.
* Proven track record leading development, submission and approval activities in one or more regions.
* Experience preparing for and leading regulatory milestone meetings and authority interactions.
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