Blackfield Associates
Senior Manager Regulatory Affairs
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Senior Manager Regulatory Affairs
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 (MAA)
- Support EMA/MHRA scientific advice and regulatory interactions
- Prepare and review MAAs; manage lifecycle activities (variations, commitments)
- Collaborate across functions (Clinical, CMC, Commercial, Business Development) to shape development
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Required Background
- 5–10 years’ experience in regulatory affairs, with focus on regulatory strategy, due diligence, and EMA/UK submissions
- Strong understanding of European regulatory requirements to inform strategic submissions for speciality products (with EU/UK emphasis)
- Integral EU regulatory expertise covering:
- Innovative pharmaceutical formulation developments (Ophthalmology, Neurology, Inhalation products, complex injectables or other innovative programs)
- Regulatory strategy definition for development programs
- Leading scientific advice procedures and managing regulatory approval processes
- Lifecycle maintenance through line extensions and MAAs
- Broad knowledge of EU market access requirements
- Degree or higher degree in pharmacy, life sciences or equivalent
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Essential Skills
- Influencing, problem-solving, time/project management
- Flexibility/adaptability, independence, multi-tasking
- Teamwork, customer focus, and cross-cultural communication
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