Head of Regulatory Strategy

Leiter der Regulierungsstrategie

Job Introduction


  • Provide overall leadership and regulatory strategic oversight in Europe for Mundipharma’s Consumer Health (CH) portfolio.
  • Lead the development of EU Regulatory Strategy for the Consumer Health portfolio and ensure optimal development and execution of regulatory plans for approval and commercialisation of Mundipharma Consumer Health products in line with business goals.
  •  Ensure optimal regulatory lifecycle management of Mundipharma’s EU Consumer health portfolio.
  • Partner with the Consumer Health business to aggressively pursue opportunities for growth and portfolio expansion in Europe and beyond.
  • Provide input to global regulatory/commercialisation strategy for Consumer Products and play a leadership role in enhancing strategic regulatory capabilities for Consumer Health products across the Mundipharma network.

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

  • Provide extensive, up-to-date regulatory expertise on current development and marketing authorisation requirements and procedures to develop innovative strategies that drive faster (to market) product development, regulatory approval and launch penetration across the European Mundipharma network for the Consumer Health portfolio.
  • Establish a focused and entrepreneurial strategic regulatory approach for Consumer Product development that is compliant with EU Regulatory guidelines and enables Mundipharma to differentiate its portfolio commercially.
  • Advise internal Mundipharma stakeholders including Senior R&D and Commercial Management, cross-functional drug development teams and representatives at our Independent Associated Companies (IACs) on the interpretation of emerging regulatory and scientific guidelines or regulatory processes and their impact on Mundipharma product development plans for Consumer Health products.
  • Lead and execute product development life cycle management strategies including new indications/geographic expansions for existing products to maximise portfolio value.
  • Coordinate and participate in new drug acquisitions/co-development as well as other business development activities, providing critical regulatory assessment and recommendations to enable Mundipharma decision making process.
  • Establish strong relationships with co-development partners to ensure delivery and effective execution of regulatory strategies in line with Mundipharma’s and Alliance partner interests.
  • Develop Mundipharma’s capabilities in obtaining, disseminating and leveraging Regulatory Affairs and Consumer Health business intelligence in a way that will confer strategic advantage to Mundipharma network of companies in the development and commercialisation of its Consumer Health product portfolio.
  • Advise regulatory leadership on formulating internal and external public company position and policy on Consumer Health regulatory matters and ensure optimal regulatory advocacy efforts on behalf of Mundipharma.

Key Competencies

  • A proven Consumer Health/OTC regulatory strategist and thought leader with a successful track record of ensuring EU/global development and registration of high value Consumer Health product assets across multiple therapeutic areas.
  • Advanced degree e.g. MSc, PhD, Pharm D or MD in a relevant scientific discipline with extensive experience in Regulatory Affairs, Drug Development or a related discipline, including experience in leading, developing and executing EU/Global Consumer Health regulatory strategy in multiple therapy areas.
  • Substantial strategic regulatory mindset coupled with commercial-nous and track record of delivering commercial advantage and business impact through innovative regulatory approaches in the Consumer Healthcare space. Is able to demonstrate ability to impact organisations approach to drug development and influence and drive change.
  • Established credibility with regulatory agencies with excellent negotiation skills and demonstrable success in influencing HA positions to ensure positive regulatory outcomes. Track record of overseeing quality regulatory submissions and approvals across EU and other territories. Experience in delivering superior Consumer Health regulatory outcomes in Emerging Markets desirable.
  • Strong leadership skills with both practical and short/long term strategic vision; ability to build relationships and inspire confidence and respect at all levels; excellent team player.
  • Outstanding communication skills; 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.
  • Ability to attract and nurture talent and to create and foster a team culture of excellence in an open and rewarding environment which promotes diversity and inclusion


Main requirements

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We Offer

This role will offer you the opportunity for personal development and will strengthen and enhance your scientific knowledge and understanding.

Contact Information

Name: Louisa Hodgson
Email: mr.hr@mundipharma-rd.eu
Telephone: 01223 424900
Adress: Mundipharma Research Ltd
196 Science Park
Milton Road
Cambridge
CB40GW

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