Regulatory Affairs Leadership Opportunity
1 day ago
Senior Director, Regulatory Affairs
Remuneration: £130,000 + Benefits per annum in Cambridge, UK (hybrid role)
Cpl Healthcare collaborates with a renowned global drug development consultancy business supporting pharma, biotechs, spin-outs, and academic groups.
Key Responsibilities:- Lead client projects providing strategic regulatory advice on gap analyses, filing routes, regulatory interactions, and designations.
- Prepare regulatory submission documents including orphan drug designation applications, clinical trial applications, and marketing authorisation applications.
- Provide leadership to a team of 4 regulatory affairs professionals supporting development plans and offering training.
- Lead regulatory agency interactions/negotiations ensuring client goals are met.
- Manage complex regulatory projects mitigating risks to timelines and budgets.
- Draft cost proposals and manage project budgets.
- Resolve internal/external project issues escalating to senior management as needed.
- Work with the Quality function to ensure compliance in regulatory affairs activities.
- At least 12+ years in Regulatory Affairs within a complex therapeutic area.
- Experience with EMA (scientific advice, orphan designation, PIPs).
- Experienced in driving global Regulatory Affairs Strategies.
- Experience working with national regulatory agencies and leading agency meetings.
- Willingness to support ongoing projects and business activities, including mentoring regulatory staff.
This role requires an office presence (2/3 days on-site per week) due to its leadership nature.
The successful candidate will have experience working in a fast-paced environment and will be able to motivate a team towards achieving company objectives.
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