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- Tasks: Lead EU regulatory strategy and manage key submissions for biopharmaceuticals.
- 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, make impactful decisions, and engage with top regulatory authorities.
- Qualifications: Life sciences education and proven EU regulatory experience in the biopharmaceutical sector 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
Make sure to showcase your leadership experience in regulatory affairs during networking opportunities. Connect with professionals in the biopharmaceutical industry who have experience with EMA interactions, as they can provide valuable insights and potentially refer you to open positions.
✨Tip Number 2
Stay updated on the latest EU regulatory changes and trends. This knowledge will not only help you in interviews but also demonstrate your commitment to the field and your proactive approach to compliance and strategy.
✨Tip Number 3
Engage with online communities and forums focused on EU regulatory affairs. Participating in discussions can help you build a network of contacts and may lead to job opportunities that are not widely advertised.
✨Tip Number 4
Consider reaching out directly to current or former employees of Planet Pharma on LinkedIn. A friendly message expressing your interest in the Director EU Regulatory Strategy position could lead to valuable insider information about the company culture and expectations.
We think you need these skills to ace Director EU Regulatory Strategy
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Director EU Regulatory Strategy position. Tailor your application to highlight your relevant experience in leading MAAs and your knowledge of EU regulatory affairs.
Highlight Relevant Experience: In your CV and cover letter, emphasize your proven experience in the biopharmaceutical industry, particularly with biologics and rare diseases. Provide specific examples of your successful engagements with the EMA and how you've navigated regulatory challenges.
Showcase Leadership Skills: Demonstrate your leadership and people management skills in your application. Include examples of how you've led cross-functional teams and managed shifting priorities in a fast-paced environment.
Craft a Compelling Cover Letter: Write a strong cover letter that not only summarizes your qualifications but also conveys your passion for regulatory strategy in the biopharmaceutical sector. Make sure to address how you can contribute to Planet Pharma's goals and regulatory success.
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, particularly in relation to biologics or rare diseases.
✨Communicate Clearly and Confidently
Strong communication skills are essential for this role. Practice articulating your thoughts clearly and confidently, especially when discussing complex regulatory strategies. This will help convey your expertise and build rapport with the interviewers.
