Regulatory Development Strategy Lead

Regulatory Development Strategy Lead

Contact length: Up to 6-month contract

Location: Remote OR Cambridge, Hybrid 

Department: Regulatory Affairs

Job type: Contract - Inside IR35

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 Regulatory Development Strategy Lead will join the Senior Leadership team in the Regulatory Affairs department at Mundipharma being accountable for global regulatory strategic leadership. The Strategy Lead will have a clinical strategy focus on regulatory strategy on ongoing clinical development.

Role and Responsibilities

• Accountable for the regulatory stewardship of assets in development and for labelling strategy across the product lifecycle and portfolios.

• Proactive engagement with Product Leads and other cross-functional partners in the development of regulatory strategies and delivery of regulatory expertise and results in line with Commercial goals.

• Accountable for provision of regulatory strategy and labelling expertise, support and advice for Due Diligence and business development activities.

• 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 development plans.

• Ensure availability of optimised regulatory strategy plans for early and late-stage Development and LCM portfolio to achieve commercially focused (differentiated) labels and expeditious approvals that maximise the assets.

• Ensure that regulatory strategies as part of the integrated product plans recognise and reflect risk, provide mitigations and ensure associated options and recommendations are adequately communicated within the organisation for appropriate decision making.

What you’ll bring

• Proven experience in Pharma regulatory affairs strategy

• Extensive regulatory leadership experience in the biotech/pharmaceutical industry with broad, in-depth knowledge and experience of early and late stage drug development.

• 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.

• 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.

• An outstanding communicator with the ability to build rapport and demonstrate strong influencing and negotiation skills; excellent listening ability – receptive to feedback and demonstrates flexibility, curiosity and an ability to learn

​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, as we focus on making a positive difference for our customers and their patients.

About Mundipharma

Mundipharma is a global healthcare company with a presence 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 and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do. 

Join our talent pool

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