At a Glance
- Tasks: Lead global regulatory strategy and labelling for innovative healthcare products.
- Company: Join Mundipharma, a global leader in patient-centric healthcare solutions.
- Benefits: Flexible benefits, learning opportunities, and a collaborative work environment.
- Other info: Diversity and inclusion are at the heart of our culture.
- 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 stakeholder engagement skills.
The predicted salary is between 43200 - 72000 € per year.
Location: Cambridge, Hybrid - Open to remote working
Department: Regulatory Affairs
Job type: Full Time
Join us and make a difference when it matters most! At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
The Team
The Global Head of Regulatory Strategy & Labelling will join the Senior Leadership team in the Regulatory Affairs department at Mundipharma being accountable for global regulatory strategic leadership and CCDS and labelling updates. The Global Head will ensure efficient, effective leadership, management and delivery of regulatory strategy and labelling strategy for the full portfolio across the product lifecycle being accountable for the internal RA strategy lead team and for oversight for outsourced RA activity.
Role and Responsibilities
- Accountable for overall Regulatory Strategy for all products including effective deployment of specific regulatory expertise to ensure portfolio regulatory deliverables are met, alignment of the strategy with RA CMC and the market clusters. Accountable for the regulatory stewardship of assets in clinical development and for labelling strategy across the product lifecycle and portfolios.
- Accountable for the successful execution of the regulatory strategy with nimble and proactive leadership of regulatory strategy revisions based on availability of new data or changes in company/commercial position. Responsible for generating global regulatory strategy plans for all products in the portfolio.
- Proactive engagement with stakeholders and senior leaders in the development of regulatory strategies and delivery of regulatory expertise and results in line with Commercial goals. Engagement with external experts and consultants as needed to support regulatory strategic decision making.
- Ensure that regulatory and Regulatory strategies fully recognise risk, provide mitigations and ensure that these are communicated and acknowledged within the organisation for appropriate decision-making.
- Accountable for optimal engagement with Regulatory Authorities in developing Mundipharma’s assets and ensuring Regulator feedback and requirements are understood and adequately reflected in product strategic and tactical plans.
- Accountable for regulatory contribution and oversight of promotional materials. Representing Regulatory as a core member of the Signal Evaluation and Labelling Group. Accountable for regulatory intelligence.
What you’ll bring
- Proven experience in Pharma Regulatory Affairs strategy and experience in managing labelling activities.
- A track record of developing and executing innovative regulatory strategies and leading successful interactions with key Health Authorities such as EMA, FDA, BfArM, MHRA, TGA, PMDA etc.
- An excellent regulatory strategist with strong commercial instincts and demonstrated ability in delivering superior regulatory outcomes across a diverse product portfolio.
- Strong understanding and expertise in Clinical Strategy.
- Demonstrated knowledge in labelling strategy and management of product labels across the product lifecycle.
- Excellent collaborator with strong customer and stakeholder focus. Able to build relationships and inspire confidence and respect at all levels, including with senior leaders within the organisation.
What we offer in return
- Flexible benefits package.
- Opportunities for learning & development through our varied programme.
- Collaborative, inclusive work environment.
Diversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.
About Mundipharma
Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.
Join our talent pool
If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, and be the first to hear about new roles.
Global Head of Regulatory Strategy & Labelling in Cambridge employer: Mundipharma International
Mundipharma is an exceptional employer, offering a collaborative and inclusive work environment in the heart of Cambridge, with flexible working options that support a healthy work-life balance. Employees benefit from a comprehensive learning and development programme, fostering personal and professional growth while contributing to innovative healthcare solutions that make a real difference in patients' lives. With a strong commitment to diversity and integrity, Mundipharma empowers its workforce to thrive and achieve their full potential.
StudySmarter Expert Advice🤫
We think this is how you could land Global Head of Regulatory Strategy & Labelling in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at Mundipharma or similar companies. A friendly chat can open doors and give you insights that might just help you land that Global Head of Regulatory Strategy & Labelling role.
✨Tip Number 2
Prepare for the interview by diving deep into Mundipharma's values and recent projects. Show us that you’re not just another candidate; you’re someone who truly understands our mission to bring innovative treatments to patients. Tailor your responses to reflect how your experience aligns with our goals.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After your interview, shoot a quick thank-you email to express your appreciation for the opportunity. It’s a simple gesture that keeps you on our radar and shows your enthusiasm for the role.
✨Tip Number 4
Keep an eye on our careers page and apply directly through our website. We love seeing candidates who are proactive and genuinely interested in joining our team. Plus, it makes the application process smoother for everyone involved!
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 to highlight your experience in regulatory strategy and labelling. We want to see how your skills align with the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Leadership Skills:As a Global Head, leadership is key! Use your application to demonstrate your ability to lead teams and manage complex projects. Share specific examples of how you've successfully navigated challenges in regulatory affairs.
Engage with Our Values:At Mundipharma, we value integrity and patient-centricity. Reflect these values in your application by discussing how you’ve prioritised patient outcomes and ethical practices in your previous roles. It’s all about showing us you fit our culture!
Apply Through Our Website:We encourage you to apply directly through our website for a smoother process. This way, you can ensure your application reaches the right people and stands out in our system. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Mundipharma International
✨Know Your Regulatory Landscape
Before the interview, brush up on the latest regulatory guidelines and frameworks relevant to the pharmaceutical industry. Familiarise yourself with key authorities like EMA and FDA, and be ready to discuss how these impact strategic decisions.
✨Showcase Your Leadership Skills
As a Global Head of Regulatory Strategy & Labelling, you'll need to demonstrate strong leadership. Prepare examples of how you've successfully led teams or projects in the past, especially in high-pressure situations where regulatory compliance was critical.
✨Engage with Stakeholders
Highlight your experience in engaging with various stakeholders, including senior leaders and external experts. Be prepared to discuss specific instances where your collaboration led to successful regulatory outcomes or improved labelling strategies.
✨Communicate Risk Management Strategies
Understanding risk is crucial in this role. Be ready to articulate how you've identified potential regulatory risks in previous roles and the strategies you implemented to mitigate them. This will show your proactive approach to regulatory stewardship.
