Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead EU regulatory strategy and manage MAA submissions while ensuring compliance.
- Company: Planet Pharma is a dynamic company focused on biopharmaceutical innovation.
- Benefits: Enjoy fully remote work with flexible hours and the chance to make an impact.
- Why this job: Join a collaborative team and shape the future of healthcare through regulatory excellence.
- Qualifications: Life sciences education and proven EU regulatory experience in biopharma required.
- Other info: This is a temporary role for 6 months, ideal for those seeking impactful work.
The predicted salary is between 72000 - 108000 £ per year.
Planet Pharma is pleased to be recruiting for a temporary Director EU Regulatory Strategy to work on an initial 6 months basis fully remote in the UK. It is imperative you can Lead an MAA and hold proven experience in the EU. Position 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 team 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 roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan · Serve as point of contact with EMA leading and managing regulatory interactions, building trusted relationships with regulatory authorities · Lead cross-functional effort 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 landscape to assess potential impact on the program; collaborate with teams to ensure compliance · Provide support to local regulatory experts in Rest of World to support applications and reviews. · 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 biopharmaceutical industry with deep understanding of EU regulatory requirements · Demonstrated experience of leading successful engagement 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 a rapidly changing and environment · Ability to travel domestically and internationally (~10%)
Director EU Regulatory Strategy employer: Planet Pharma
Contact Detail:
Planet Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director EU Regulatory Strategy
✨Tip Number 1
Make sure to highlight your experience with the European Medicines Agency (EMA) in your conversations. This role requires a strong background in leading successful engagements with regulatory authorities, so be prepared to discuss specific examples of how you've navigated these interactions.
✨Tip Number 2
Familiarize yourself with the latest EU regulatory requirements and trends in the biopharmaceutical industry. Being up-to-date will not only help you in discussions but also demonstrate your commitment to staying informed in this rapidly changing environment.
✨Tip Number 3
Network with professionals in the regulatory affairs field, especially those who have experience with biologics and rare diseases. Building relationships can provide valuable insights and may even lead to referrals or recommendations for the position.
✨Tip Number 4
Prepare to discuss your leadership style and how you manage cross-functional teams. This role emphasizes strong leadership and people management skills, so be ready to share examples of how you've successfully led teams through complex regulatory processes.
We think you need these skills to ace Director EU Regulatory Strategy
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Director EU Regulatory Strategy position. Highlight key responsibilities and requirements that align with your experience, especially in leading MAAs and engaging with the EMA.
Tailor Your CV: Customize your CV to emphasize your relevant experience in the biopharmaceutical industry, particularly your understanding of EU regulatory requirements and any leadership roles you've held. Use specific examples that demonstrate your expertise in biologics and rare diseases.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your strategic vision for the role. Address how your background aligns with the responsibilities listed, such as developing regulatory roadmaps and managing agency interactions.
Highlight Communication Skills: Since strong written and verbal communication skills are essential for this role, ensure that your application reflects your ability to communicate complex regulatory concepts clearly. Provide examples of successful stakeholder engagement and cross-functional collaboration.
How to prepare for a job interview at Planet Pharma
✨Showcase Your Regulatory Expertise
Make sure to highlight your deep understanding of EU regulatory requirements and your experience in leading successful engagements with the EMA. Prepare specific examples that demonstrate your thought leadership in regulatory affairs.
✨Demonstrate Strategic Thinking
Be ready to discuss how you would develop a regulatory roadmap and engage with key stakeholders. Share your approach to identifying regulatory risks and opportunities, and how you would work collaboratively to find solutions.
✨Highlight Leadership Skills
Since this role requires strong leadership and people management skills, prepare to talk about your experience in leading cross-functional teams. Provide examples of how you've successfully managed shifting priorities in a dynamic environment.
✨Communicate Effectively
Strong written and verbal communication skills are essential for this position. Practice articulating your thoughts clearly and concisely, and be prepared to discuss how you build trusted relationships with regulatory authorities.
