Regulatory Strategy Lead
6 hours ago
Planet Pharma is a leading pharmaceutical company seeking a highly skilled Regulatory Strategy Lead to join our team on a temporary basis, working remotely in the UK. The initial 6-month contract offers an excellent opportunity for experienced professionals to showcase their expertise.
The successful candidate will be responsible for leading MAA reviews, including responding to List of Issues and EU-SmPC negotiations. They will also develop regulatory roadmaps to inform agency engagement strategies and collaborate with key stakeholders to implement comprehensive regulatory plans.
We are looking for a seasoned professional with proven experience in biopharmaceutical industry, holding deep understanding of EU regulatory requirements. Demonstrated expertise in leading successful engagements with EMA is essential, while experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases is highly desirable.
In this role, you will serve as a thought leader on regulatory affairs, defining European regulatory strategy and plan to maximize regulatory success. You will provide strategic and operational input to program teams to achieve objectives while ensuring compliance with applicable regulatory requirements.
Salary: £80,000 - £100,000 per annum, depending on experience
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