At a Glance
- Tasks: Lead global regulatory strategy and labelling for innovative healthcare products.
- Company: Mundipharma, a global leader in healthcare focused on patient-centric solutions.
- Benefits: Flexible benefits, learning opportunities, and a collaborative work environment.
- Other info: Join a diverse team committed to inclusion and professional growth.
- Why this job: Make a real impact in healthcare by shaping regulatory strategies for life-changing treatments.
- Qualifications: Proven experience in Pharma Regulatory Affairs and strong strategic skills.
The predicted salary is between 80000 - 100000 £ per year.
The Global Head will lead global regulatory strategy and labelling across the full product portfolio. Key responsibilities include:
- Accountable for overall regulatory strategy for all products, ensuring alignment with CMC and market clusters.
- Stewardship of assets in clinical development and responsibility for labelling strategy across product lifecycle.
- Execution of regulatory strategy, revising plans as new data or commercial positions arise.
- Generate global regulatory strategy plans for all products in the portfolio.
- Engage stakeholders and senior leaders to develop strategies and deliver regulatory expertise aligned with commercial goals.
- Engage external experts and consultants to support strategic decision‑making.
- Identify regulatory risks, propose mitigations, and communicate them within the organization.
- Maintain optimal engagement with Regulatory Authorities to incorporate their feedback into product plans.
- Oversee regulatory contribution to promotional materials.
- Represent Regulatory in the Signal Evaluation and Labelling Group.
- Provide regulatory intelligence.
Qualifications and Experience
- Proven experience in Pharma Regulatory Affairs strategy and managing labelling activities.
- Track record of developing and executing innovative regulatory strategies with interactions with key Health Authorities (EMA, FDA, BfArM, MHRA, TGA, PMDA, etc.).
- Excellent regulatory strategist with strong commercial instincts and ability to deliver superior outcomes across a diverse portfolio.
- Strong understanding and expertise in Clinical Strategy.
- Demonstrated knowledge in labelling strategy and management of product labels across lifecycle.
- Excellent collaborator with strong customer and stakeholder focus.
- Ability to build relationships and inspire confidence at all levels, including senior leaders.
Benefits
- Flexible benefits package.
- Opportunities for learning & development through varied programmes.
- Collaborative, inclusive work environment.
- Diversity and inclusion commitment, fostering an environment where everyone can thrive.
About the Company
Mundipharma is a global healthcare company focusing on pain management, infectious disease, and other severe therapeutic areas. Guided by integrity and patient‑centricity, we bring innovative treatments globally.
Global Head of Regulatory Strategy & Labelling in Cambridge employer: Mundipharma Research Limited
Mundipharma is an exceptional employer, offering a collaborative and inclusive work environment in Cambridge, with the flexibility of hybrid and remote working options. Employees benefit from a comprehensive flexible benefits package and numerous opportunities for professional growth and development, all while contributing to meaningful healthcare solutions that make a difference in patients' lives.
Contact Details:
Mundipharma Research Limited Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Global Head of Regulatory Strategy & Labelling in Cambridge
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups. The more you engage with others, the better your chances of hearing about opportunities that might not even be advertised.
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back! Share your insights on regulatory strategies and labelling. This will not only showcase your knowledge but also demonstrate your passion for the field.
✨Tailor Your Approach
Every company is different, so make sure you tailor your conversations to fit their specific needs. Research Mundipharma’s values and recent projects, and align your skills and experiences with what they’re looking for.
✨Apply Through Our Website
Don’t forget to apply directly through our website! It shows initiative and gives you a better chance of being noticed. Plus, we love seeing candidates who are genuinely interested in joining our team.
We think you need these skills to ace Global Head of Regulatory Strategy & Labelling in Cambridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Global Head of Regulatory Strategy & Labelling role. Highlight your experience in Pharma Regulatory Affairs and any innovative strategies you've developed that align with our needs.
Showcase Your Expertise:Don’t hold back on showcasing your knowledge in labelling strategy and clinical development. We want to see how your background can contribute to our diverse portfolio and help us achieve superior outcomes.
Engage with Our Values:At StudySmarter, we value integrity and patient-centricity. Make sure to reflect these values in your application. Share examples of how you’ve prioritised these principles in your previous roles.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity in our collaborative environment.
How to prepare for a job interview at Mundipharma Research Limited
✨Know Your Regulatory Landscape
Familiarise yourself with the latest regulations and guidelines from key Health Authorities like EMA, FDA, and MHRA. This will not only show your expertise but also demonstrate your commitment to staying updated in the field.
✨Showcase Your Strategic Thinking
Prepare examples of how you've developed and executed innovative regulatory strategies in the past. Be ready to discuss specific challenges you faced and how you overcame them, as this will highlight your problem-solving skills.
✨Engage Stakeholders Effectively
Think about how you can engage with various stakeholders, including senior leaders and external experts. Prepare to discuss your approach to building relationships and inspiring confidence, as collaboration is key in this role.
✨Demonstrate Your Labelling Expertise
Be prepared to talk about your experience with labelling strategy and management across the product lifecycle. Bring examples of how you've navigated complex labelling issues and how you ensured compliance while aligning with commercial goals.
