Head of Regulatory and PV intelligence

Leiter der Aufsichts- und PV-Intelligenz

Job Introduction

  • Partner with Regulatory Strategy Leads, Safety Strategy Leads and CMC Leads to provide intelligence input into strategic regulator and safety/pharmacovigilance (PV) analysis to inform asset team and due diligence team decisions and contribute to Mundipharma’s commercial excellence goals
  • Development of the necessary systems and tools to support regulatory and PV intelligence within DSRA and across Mundipharma in Europe and rest of world
  • 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

·       Analysis & Reporting:
o   Provide strategic regulatory and PV intelligence analysis to inform decision-making, including in response to ad hoc queries from asset teams and other stakeholders.
o   Prepare periodic regulatory and PV intelligence reports that analyse the strategic significance of recent past and forthcoming regulatory events and their potential impact on the Mundipharma portfolio in EU and RoW.
o   Provide pro-active interpretive analysis with context and novel insight, and to go beyond merely gathering and organizing information.
 
·       Systems & Processes:
o   Develop internal and external Regulatory Intelligence tools, and leverage these tools to create, distribute and archive intelligence reports and  deliverables.
o   Lead or participate as assigned, in routine evaluations of new information sources and tools, (e.g. dashboards, databases, machine learning, artificial intelligence, repositories), looking for both content usefulness and toward automating the process of collecting, analysing, disseminating, and archiving of regulatory intelligence for additional use.
o   Lead or participate in system and process improvement/implementation activities as assigned.
o   Drive the development of regulatory intelligence expertise and capabilities and the development of a focused and effective Regulatory/PV Intelligence network within Mundipharma that mitigates emerging portfolio risks and contributes to Mundipharma’s competitive advantage.
·       Collaboration:
o   Collaborate with regulatory strategy, safety strategy, labelling and CMC leads and other Mundipharma stakeholders including IAC to support policy activities both at the productand at all levels of the organisation.
o   Partner with regulatory leads and sub teams to identify opportunities to accelerate development by leveraging novel regulatory approaches while mitigating risks.
o   Collaborate with other internal intelligence and policy staff within Mundipharma to provide context and broader perspective to increase the value of deliverables.
o   Establish and leverage internal and external networks to gather intelligence and insight that is not available from published sources.
o      Represent Mundipharma drug safety and regulatory affairs department at relevant external meetings, including global regulatory agency meetings, 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
·       Horizon Scanning & Knowledge Management:
o   Systematically monitor information systems to collect and disseminate relevant, focused regulatory intelligence alerts and analysis on emerging issues and relevant events.
o   Ensure the development of knowledge and enhance the awareness of DSRA and broader Mundipharma organisation on key intelligence topics and areas that are of strategic value to the business
·       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

A.    Qualifications & Experience
·    Science degree or equivalent qualification: with extensive regulatory or pharmacovigilance  experience working in research-based drug development role
·       Extensive regulatory experience in the biotech/pharmaceutical industry with a broad, in-depth knowledge gained from a regulatory intelligence, policy or analyst role that included substantial experience interacting with Health Authorities
·      Demonstrable knowledge of the drug lifecycle (research, development and commercial) process, and how the external environment can shape regulatory/ compliance outcomes.
·       Experience in effective information and knowledge management principles and techniques. An understanding of applied principles of information storage and management including the use of internet/intranet based solutions to post, organise, and retrieve material from wide range of databases and web-based tools.
  
B.    Personal & Leadership Characteristics
·       Ability to evaluate utility of external resources for collecting regulatory & safety intelligence, with a focus on customer needs and the ability to manage multiple projects and stakeholders
·      A strong analytical mind-set and demonstrated ability in representing the company to various regulatory health authorities in both diplomatic and persuasive ways
·       High functioning as both a team player and individual contributor.
·     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.

We Offer

We 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, Milton Road

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