Current jobs related to Regulatory Affairs Project Lead with EU Focus - Copenhagen, Copenhagen - Genmab

  • EU Regulatory Affairs Expert

    1 week ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    The EU Regulatory Affairs Expert will play a critical role in shaping the company's EU regulatory strategy and ensuring compliance with EU/ROW regulatory requirements.Responsibilities will include:Developing and implementing EU regulatory strategies for assigned projectsClosely collaborating with the Global Regulatory Team to ensure compliance with EU/ROW...

  • Global Regulatory Affairs Project Lead

    2 weeks ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Transform the future of cancer treatment and serious diseases as a member of our Global Regulatory Affairs organization.The RoleYou will be responsible for representing RA in Clinical Trial Teams, ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW.This role involves working closely with CROs and internal stakeholders to...

  • Global Regulatory Affairs Project Lead

    4 hours ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    About the RoleThe Director, Global Regulatory Affairs Project Lead will join our team in a key role, overseeing EU/ROW regulatory strategy and collaboration with the Global Regulatory Team. As the representative of RA on Clinical Trial Teams, this individual will ensure regulatory oversight of clinical trial submission activities. The chosen candidate will...

  • Regulatory Affairs Project Manager

    1 week ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Job DescriptionWe are seeking an experienced and skilled professional to lead our EU/ROW regulatory strategy. As a key member of our Global Regulatory Affairs team, you will be responsible for developing and executing the EU/ROW strategy for one or multiple compounds in early or late-stage development.Key Responsibilities:Develop and execute EU/ROW...

  • Regulatory Strategy Lead

    7 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    About the RoleWe are looking for a highly skilled and passionate leader to be part of our Global Regulatory Affairs organization. In this role, you will assume responsibility for the EU/ROW regulatory strategy for an assigned program and manage a group of Regulatory Strategists with EU/ROW responsibilities for our programs across all stages of...

  • Global Regulatory Affairs Project Manager

    2 weeks ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Job DescriptionWe are seeking a skilled and experienced Global Regulatory Affairs Project Manager to join our team. As a key member of our organization, you will play a vital role in ensuring the success of our clinical trials.Your primary responsibility will be to represent Regulatory Affairs in Clinical Trial Teams and work closely with CROs and internal...

  • Regulatory Affairs Project Manager

    5 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    We are seeking a highly skilled Regulatory Affairs Project Manager to join our team. As a key member of our Global Regulatory Affairs organization, you will be responsible for leading the preparation of strategic regulatory documents, such as briefing packages, ODDs, and PIPs. You will also plan, prepare, and lead EMA or national scientific advice...

  • Global Regulatory Affairs Project Lead

    1 week ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    The Global Regulatory Affairs Project Lead will play a critical role in the development and execution of EU/ROW regulatory strategies for assigned projects. This includes acting as the EU/ROW regulatory lead and EMA contact person, ensuring oversight and progress of multiple clinical trial submission activities.Key Responsibilities:Evaluate competitive...

  • Regulatory Affairs Project Lead

    1 week ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Job DescriptionWe are seeking a highly skilled and experienced Regulatory Affairs Project Lead to join our Global Regulatory Affairs organization.In this role, you will represent RA in the Clinical Trial Teams and work closely with stakeholders to ensure regulatory oversight and progress of clinical trial submissions. You will also be responsible for...

  • EU/ROW Regulatory Strategy Lead

    2 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    We are seeking a highly motivated and experienced individual to lead our EU/ROW Regulatory Strategy efforts. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring the success of our clinical trials in Europe and Rest of World regions.This role requires a deep understanding of EU regulatory procedures, as well as...

Regulatory Affairs Project Lead with EU Focus

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

We are looking for a highly skilled Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will be responsible for ensuring regulatory compliance and facilitating the successful execution of clinical trials in the EU and ROW regions.

About the Role

In this position, you will be responsible for representing RA in the Clinical Trial Teams and working closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions. You will also act as EU/ROW regulatory lead for assigned projects and be responsible for developing and executing EU/ROW strategies.

Key Responsibilities:

  • Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple clinical trial submission activities.
  • Act as EU/ROW regulatory lead for assigned projects and be responsible for developing and executing EU/ROW strategies.
  • Lead the preparation of strategic regulatory documents, such as briefing packages, ODDs, PIPs, etc.
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
  • Maintain knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes.

Requirements:

  • A minimum of a Bachelor's degree or equivalent in a scientific discipline or health-related field. A Master's degree is preferred.
  • Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase.
  • Experience in proactively planning and executing complex clinical submission strategies.
  • A good understanding of drug development and EU regulatory procedures.
  • Prior experience leading health authority meetings with the EMA or other health authorities.
  • Strong project management skills.