Senior Regulatory Affairs Manager – Europe (Speciality Products)
Blackfield Associates are supporting a growing pharmaceutical organisation seeking a Senior Regulatory Affairs Manager to lead EU/UK regulatory strategy and due diligence across a portfolio of speciality products.
This role sits at the core of decision‑making for late‑stage assets (Phase II/III) and in‑licensing opportunities, with direct impact on development strategy, regulatory pathways, and time to market.
Key Responsibilities
- Lead regulatory due diligence for speciality assets (e.g. Ophthalmology, Neurology, Respiratory)
- Assess clinical, non‑clinical, and CMC data (Modules 1–5) to identify risks and gaps
- Define EU/UK regulatory strategies and recommend pathways to Marketing Authorisation
- Support EMA/MHRA scientific advice and regulatory interactions
- Prepare/review MAAs and manage lifecycle activities (variations, commitments)
- Collaborate cross‑functionally (Clinical, CMC, Commercial, BD) to shape development
Required Background:
- 5–10 years’ experience in regulatory affairs, including regulatory strategy, due diligence, and EMA/UK submissions.
- Excellent understanding of European regulatory requirements to define regulatory strategies in support of development programs for speciality products with focus on EU and UK.
- Significant EU regulatory experience with innovative pharmaceutical formulation developments (Ophthalmology, Neurology, Inhalation products, complex injectables or other innovative product development programs) defining regulatory strategy in support of the development program, leading scientific advice procedures, managing regulatory approval processes and line extension applications through to the granting of the MA and lifecycle maintenance.
- Broad understanding of the requirements to place products on the market within EU.
- Degree or higher degree in pharmacy, life sciences or equivalent.
The following skills are essential for the role: Influencing, problem solving, time and project management, flexibility/adaptability, independence, multi-tasking, teamwork, customer focus and effective inter-cultural communication skills.
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