Regulatory Affairs Director
14 hours ago
Planet Pharma is a leading pharmaceutical company with a strong presence in the UK, seeking an experienced Regulatory Affairs Director to lead our EU regulatory strategy.
The successful candidate will have a deep understanding of EU regulatory requirements and a proven track record of leading successful engagements with the European Medicines Agency (EMA).
This is a full-time remote position, initially for 6 months, with the possibility of extension. The salary range for this role is £80,000 - £120,000 per annum, depending on experience.
Key Responsibilities:
- Serve as a thought leader on regulatory affairs, defining European regulatory strategy and plan to maximize regulatory success.
- Provide strategic and operational input to program teams to achieve program objectives while ensuring compliance with applicable regulatory requirements.
- Lead MAA review, including response to List of Issues and EU-SmPC negotiations.
- Develop regulatory roadmaps to inform and guide agency engagement strategies; partner with key stakeholders to develop and implement comprehensive regulatory engagement plans.
- Serve as the point of contact with EMA, leading and managing regulatory interactions, building trusted relationships with regulatory authorities.
- Lead cross-functional efforts to ensure timely submission of key regulatory documents (e.g., IND, briefing documents, DSUR, BLA).
- Identify regulatory risks and opportunities and work with key stakeholders to develop solutions.
- Maintain currency of EU regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance.
- Monitor and analyze global and country-specific regulatory landscapes to assess potential impacts on programs; collaborate with teams to ensure compliance.
- Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed.
Requirements:
- Education in life sciences required.
- Proven experience in the biopharmaceutical industry with a deep understanding of EU regulatory requirements.
- Demonstrated experience of leading successful engagements with EMA.
- Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred.
- Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills.
- Strong written, verbal communication skills, and interpersonal skills.
- Capable of managing shifting priorities in rapidly changing environments.
- Ability to travel domestically and internationally (~10%).
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