Regulatory Affairs Manager – Speciality Medicine
A European‑focused regulatory role supporting the development, registration, and lifecycle management of speciality, orphan, paediatric, and generic medicines.
Key Responsibilities
* Develop and execute EU regulatory strategies for innovative, speciality, and complex products.
* Review non‑clinical and clinical data packages and identify gaps for regulatory submissions.
* Lead/assist with MAAs, variations, line extensions, renewals, and post‑approval commitments.
* Support regulatory interactions, including scientific advice and dossier due diligence (Modules 1–5).
* Coordinate registrations across centralised, DCP, MRP, and national procedures.
* Provide input across cross‑functional development teams and oversee documentation systems.
* Support EU launch requirements and guide junior team members where needed.
Required Experience
* Experience with ophthalmology products (eye drops, ophthalmic solutions).
* Experience leading Health authority interactions and scientific advice meetings
* Knowledge of medical devices/combination products, ideally ophthalmic.
* Proven background in injectable/sterile products and related regulatory submissions.
* Strong EU regulatory experience including MAAs, DCP/MRP, lifecycle management, and scientific advice.
* Understanding of requirements for placing medicines on the EU market.
* Hands on, proactive regulatory with authoring and submission experience
Skills & Qualifications
* Degree in Pharmacy, Life Sciences, or similar.
* Proficient with regulatory tools (eCTD publishing, CESP, MHRA Portal, etc.).
* Strong analytical, communication, and project‑management capabilities.
* Must be a proven regulatory SME in speciality pharma
Due to the nature of this roles hands-on, fast pace work, this role is not suitable for Regulatory Project Manager or those who have not directly authored dossier and lead review of both clinical and non clinical data package. All applicants must have clearly demonstrated experience with health authority interaction as an active/ leading member of meetings.
Hybrid role with weekly office presence. Unable to sponsor, candidates must hold valid Right to Work in the UK.