Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs focuses on 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.

What the role involves

• 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.
• Leading 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.
• Supporting EMA/MHRA scientific advice and regulatory interactions.
• Manage lifecycle activities (variations, commitments).

Skills and requirements

• 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.
• Broad understanding of the requirements to place products on the market within EU.
• Degree or higher degree in pharmacy, life sciences or equivalent.