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Valby

    Associate Director, EU/ROW Regulatory Lead - Valby, Danmark - Genmab A/S

    Genmab A/S
    Genmab A/S Valby, Danmark

    for 1 uge siden

    Genmab A/S background
    Fuldtid
    Beskrivelse

    The Role

    Genmab is looking for a Senior Manager/Associate Director, EU/ROW Regulatory Lead to be a part of our Global Regulatory Affairs organization.

    In this role, the candidate will represent RA in the Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of the clinical trial submissions in EU/ROW. The candidate may also be allocated as EU/ROW Regulatory Strategy Lead to one or multiple compounds in early or late development and provide regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team to ensure an optimal EU/ROW regulatory strategy for the compound. The position is based in Copenhagen and will report to the EU/ROW Regulatory Strategy Team Lead.

    Responsibilities

    The responsibilities of the role will include, but is not limited to:

  • Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
  • Represent EU/ROW in the Global Regulatory Team(s).
  • Act as EU/ROW Regulatory Lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW regulatory strategy.
  • Lead the preparation of strategic regulatory documents, e.g. Briefing Packages, ODDs, PIPs, etc.
  • Plan, prepare and lead EMA or national Scientific Advice procedures, as relevant.
  • Evaluate regulatory risks and recommend mitigation strategies to the cross-functional teams and management.
  • Monitor and assess regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
  • Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working.

    Requirements

  • A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. Master's degree preferred.
  • Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.
  • Experience in proactively planning and executing highly complex clinical submission strategies.
  • Prior experience leading health authority meetings with the EMA or other health authorities.
  • A good understanding of drug development and EU regulatory procedures.
  • Experience within oncology and/or I&I will be a plus.
  • Experience with PIPs will be a plus.
  • Experience with development and regulatory requirements in ROW markets will be a plus.
  • Strong project management skills. Moreover, you meet the following personal requirements:
  • Strong organizational, communication, and time management skills needed to lead multiple ongoing projects simultaneously.
  • Must have attention to detail and be able to solve problems with minimal supervision.
  • Be able to work independently with an ability to drive projects to successful outcomes.
  • Robust cross-functional teamwork skills and enjoy working in a global environment.
  • Skills in building and maintaining internal and external collaborative relationships to achieve shared goals.
  • Highly motivated and dedicated individual who enjoys being challenged.
  • Able to prioritize your work in a fast paced and changing environment.
  • Goal-oriented and committed to contributing to the overall success of Genmab. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly motivated team members across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer. About You
  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do soLocations Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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