Senior Director, Regulatory Affairs Strategy-EU/RoW
3 days ago
About the Role
In this key position, you will assume responsibility for the EU/ROW regulatory strategy for assigned programs and lead a group of Regulatory Strategists with EU/ROW responsibilities. Your ultimate goal will be to ensure an optimal development and implementation of an EU/ROW regulatory strategy for Genmab's programs.
Key Responsibilities
- Develop global regulatory strategies for assigned projects through integration of regional regulatory strategies and in line with global development and commercial goals.
- Lead or be responsible for the planning and implementation of regional regulatory procedures (e.g., clinical trial applications, marketing applications, label extensions, CMC changes, PIPs).
- Represent Regulatory Affairs across Genmab committees as indicated.
- Evaluate and communicate to senior management regulatory risks and challenges, and mitigation options.
- Oversee CRO quality, accountabilities and deliverables related to Regulatory activities.
- Assess EU and MHRA regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
- Interact with health authorities and lead/participate in health authority meetings.
- Present the regulatory strategy/position to senior management and health authorities, as appropriate.
Requirements
- A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. PhD or MD degree will be preferred.
- Minimum of 10 years of experience in Regulatory Affairs, across all development phases.
- Significant experience in proactively planning and implementing highly complex clinical submission strategies.
- Experience in leading a team of regulatory strategist professionals.
- Expertise in drug development and EU regulatory mechanisms to expedite development.
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.
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Copenhagen, Copenhagen, Denmark Genmab Full timeJob Title: Senior Director, Regulatory Affairs Strategy-EU/RoWGenmab is seeking a highly experienced Senior Director to lead our Regulatory Affairs team in EU/ROW. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing EU/ROW regulatory strategies for our programs, managing a team of Regulatory...
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Copenhagen, Copenhagen, Denmark Genmab Full timeJob Title: Senior Director, Regulatory Affairs Strategy-EU/RoWGenmab is seeking a highly experienced Senior Director to lead our Regulatory Affairs team in the EU/ROW region. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing regulatory strategies for our programs across all stages of...
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Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleAs a Senior Director, Regulatory Affairs Strategy-EU/RoW, you will assume responsibility for the EU/ROW regulatory strategy for an assigned program and will manage a group of Regulatory Strategists with EU/ROW responsibilities for our programs across all stages of development. The chosen candidate may act as the deputy for the Head of Regulatory...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly experienced Senior Director to lead our Global Regulatory Affairs organization in the EU/ROW region. As a key member of our team, you will be responsible for developing and implementing an optimal EU/ROW regulatory strategy for our programs, ensuring seamless integration with our global clinical development and...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled Senior Director, Regulatory Affairs Strategy-EU/RoW to join our Global Regulatory Affairs organization. In this critical role, you will assume responsibility for the EU/ROW regulatory strategy for assigned programs and manage a group of Regulatory Strategists with EU/ROW responsibilities.Key...
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Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleAs a Senior Director, Regulatory Affairs Strategy-EU/RoW, you will be responsible for leading the EU/ROW regulatory strategy for assigned programs and managing a team of Regulatory Strategists. This role will involve assuming responsibility for the EU/ROW regulatory strategy for assigned programs and managing a group of Regulatory Strategists with...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking an experienced and passionate leader to join our Global Regulatory Affairs organization as a Senior Director, Regulatory Affairs Strategy-EU/RoW. In this role, you will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products. You will provide...
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