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- Tasks: Lead EU regulatory strategy and ensure compliance for biopharmaceutical programs.
- Company: Planet Pharma is a dynamic company focused on innovative solutions in the biopharmaceutical industry.
- Benefits: Enjoy fully remote work flexibility and the opportunity to shape regulatory strategies.
- Why this job: Join a collaborative team and make a significant impact in the biopharmaceutical landscape.
- Qualifications: Life sciences education and proven experience in EU regulatory affairs required.
- Other info: This is a temporary position for 6 months with potential for future opportunities.
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
Familiarize yourself with the latest EU regulatory guidelines and frameworks. This will not only help you understand the landscape but also demonstrate your commitment to staying updated, which is crucial for a role like this.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, especially those who have experience with EMA interactions. Building relationships can provide insights and potentially lead to referrals that could strengthen your application.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led MAA reviews or navigated complex regulatory challenges in the past. Being able to articulate your experience clearly will set you apart during discussions.
✨Tip Number 4
Stay informed about current trends and changes in the regulatory environment, particularly regarding biologics and rare diseases. This knowledge will be invaluable in demonstrating your expertise and strategic thinking during interviews.
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 thought leadership in regulatory affairs. Discuss how your strategic input has led to successful program outcomes and how you can contribute to Planet Pharma's objectives. Be sure to mention your ability to build relationships with regulatory authorities.
Highlight Communication Skills: In both your CV and cover letter, emphasize your strong written and verbal communication skills. Provide examples of how you've effectively communicated complex regulatory information to diverse stakeholders, as this is crucial for the role.
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 from your past roles that demonstrate your ability to navigate complex regulatory landscapes.
✨Demonstrate Leadership Skills
As a Director, strong leadership is crucial. Be ready to discuss your experience in managing cross-functional teams and how you've successfully led initiatives in the biopharmaceutical industry. Share instances where you built trusted relationships with stakeholders.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to manage shifting priorities. Think of scenarios where you identified regulatory risks and developed solutions, and be prepared to explain your thought process.
✨Communicate Clearly and Effectively
Strong written and verbal communication skills are essential for this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory strategies or compliance issues. This will help you make a positive impression during the interview.
