Global Head of Regulatory Strategy & Labelling

Global Head of Regulatory Strategy & Labelling

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

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

The Global Head of Regulatory Strategy & Labelling will have a clinical strategy focus on regulatory strategy on both marketed products and ongoing clinical development. Main responsibilities for the role will include:

• 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.

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