Senior Director, Regulatory Affairs Strategy-EU/RoW
2 months ago
Genmab 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 strategic input and ensure operational execution of global submission activities, interfacing directly with EMA as the primary contact for assigned programs and overseeing regulatory CROs for territory outside of Japan and US.
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, such as clinical trial applications, marketing applications, label extensions, CMC changes, and PIPs.
- Represent Regulatory Affairs across Genmab committees as indicated.
- Proactively and in a timely manner, evaluate and communicate to senior management regulatory risks and challenges, and mitigation options.
- Follow all correspondence with competent authorities across programs from EU/ROW.
- 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.
- Evaluate regulatory mechanisms that allow optimization of product development, such as orphan drug designation, PRIME designation, compassionate use, and pediatric plans, and ensure that they are implemented, if applicable.
- Ensure compliance with all internal and external requirements and procedures related to Regulatory Affairs.
- Participate in regulatory SOP development.
- Provide input into streamlining internal RA processes.
- 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.
- Experience within oncology is preferred.
- Prior experience leading health authority meetings with the EMA or other health authorities.
- Experience with submitting and bringing to completion MAAs in Europe/ROW.
- Experience with variation procedures.
- Strong project management skills.
- 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 so.
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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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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.Key ResponsibilitiesManagerial/supervisory responsibilities.Actively...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs organization in the EU/ROW region. As a key member of our global team, you will be responsible for developing and implementing regulatory strategies for our programs across all stages of development.Key ResponsibilitiesDevelop and implement global regulatory...
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeSenior Director, Regulatory Affairs Strategy-EU/RoW Genmab is seeking a highly experienced and skilled Regulatory Affairs leader to join our Global Regulatory Affairs organization. This key role will be responsible for the development of global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products. The...
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