Regulatory Strategy Lead

Regulierungsstrategie führen

Job Introduction

·       Develop and lead regulatory strategies and drive the execution of registration plans for development,              regulatory approval and optimal market access of Mundipharma pipeline/portfolio  in Europe, Latin                  America, Middle East, Africa and Asia as well as US and Canada as required
·       Provide regulatory advice and expertise to R&D and commercial project team counterparts for business            development and other activities related to developing and enhancing the value of Mundipharma’s                  pipeline.
·       Contribute to the development of people and foster Mundipharma’s core values through mentoring,                coaching and acting as a role model for all staff in regulatory affairs.

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

Provide regulatory expertise to optimise drug development and drug registration and access strategies on assigned projects: • Serve as the Regulatory Affairs lead representative on the product development Asset Team • Provide regulatory expertise on current drug development and marketing authorisation requirements and procedures to develop faster to market product development and approval strategies with optimal labelling. • Lead the development of the Strategic Regulatory Plan for the assigned project(s) including assessment of the probability of regulatory success together with risk mitigation measures and deliver regulatory milestones in accordance with the plan • Ensure the delivery of high quality submissions (CTA/IND, MAA/NDA, orphan drug designation, scientific advice applications) in a timely manner • Initiate and manage appropriate responses to agency review issues, ensuring efficient review and approval of submissions within assigned timelines • Maintain awareness of emerging regulatory and scientific guidance on general and specific topics of relevance to the assigned therapeutic area(s) and their impact on current Mundipharma product development plans • Undertake due diligence activities as requested by the co-ordinating Head of Regulatory Strategy and provide critical regulatory assessment and recommendations to enable Mundipharma’s decision making process • Contribute to the strategic drug development regulatory teams, improving quality of regulatory strategies, planning and promoting the function as a whole • Represent Mundipharma at relevant external meetings, including global regulatory agency meetings, scientific and HTA advisory boards and trade association meetings. Use knowledge in regulatory affairs and standing in the regulatory community to influence widely Mundipharma’s ability to undertake drug development and product registrations • Take ownership of individual objectives, and be accountable in achieving results while embracing Mundipharma core values. Facilitate teamwork, undertake mentoring and provide guidance to team members as needed

Key Competencies

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Main requirements

  • Degree or equivalent in a relevant scientific discipline. 
  • Extensive regulatory experience in the biotech/pharmaceutical industry with a broad, in-depth knowledge and experience of drug development and approval requirements.
  • A track record of overseeing a substantial number and quality of drug development submissions and approvals, including CTA/INDs and MAA/NDAs working with or from within health authorities such as EMA, FDA, BfArM, MHRA, TGA, PMDA and others.
  • Knowledge, experience and track record of delivering successful regulatory outcomes for new products across various territories including US, EU, Asia. Fully conversant with strategic development/regulatory considerations and opportunities for accelerated approval, conditional approval and other regulatory processes for expediting access in the above-mentioned territories
  • Proven ability to manage complex projects and delivering results in a matrix environment.
  • A strong strategic regulatory mind-set and demonstrated ability in leading company interactions with various regulatory health authorities across diverse issues in diplomatic and persuasive ways
  • 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
  • Consistently demonstrates and encourages others to adhere to the Company’s Core Values Honesty, Respect, Passion, Innovation and Commitment.



Contact Information

Name: Louisa Hodgson
Email: mrhr@mundipharma-rd.eu
Telephone: 01223 424900

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