Senior Director of Regulatory Excellence
3 days ago
We are looking for a highly skilled Regulatory Strategy and Operations Manager to join our team at Genmab. As a key member of our Regulatory Affairs organization, you will play a critical role in developing and executing global strategies to advance our portfolio of development pipeline candidate drugs and marketed products.
Key Responsibilities- Develop and implement global regulatory strategies for assigned projects, ensuring alignment with our global development and commercial goals.
- Lead or be responsible for planning and implementing regional regulatory procedures, including clinical trial applications, marketing applications, label extensions, CMC changes, and PIPs.
- Collaborate with cross-functional teams to ensure effective communication and coordination throughout the product lifecycle.
- Evaluate and mitigate regulatory risks and challenges, providing recommendations to senior management.
To succeed in this role, you will need:
- A minimum of 10 years of experience in Regulatory Affairs, across all development phases.
- Significant experience in proactively planning and implementing complex clinical submission strategies.
- Experience leading a team of regulatory strategist professionals.
- Expertise in drug development and EU regulatory mechanisms to expedite development.
- Prior experience leading health authority meetings with the EMA or other health authorities.
- Experience submitting and bringing to completion Marketing Authorization Applications (MAAs) in Europe/ROW.
- Experience with variation procedures.
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Global Regulatory Affairs Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeRegulatory Submission Manager PositionWe seek an experienced Regulatory Submission Manager to manage submissions for MAA, BLA, and IND applications, collaborate with cross-functional teams, and drive timely delivery of submission documents.Key ResponsibilitiesOversee submission management to ensure compliance and accuracyDevelop and maintain relationships...
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Regulatory Strategy and Operations Manager
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We are seeking a talented Senior Director to lead our Global Regulatory Affairs organization and drive our strategic initiatives forward.Job...
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Global Regulatory Affairs Strategic Lead
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Regulatory Affairs CMC Leadership Role
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Senior Medical Director for Nordic Countries
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EU Regulatory Specialist
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Senior Document Coordinator
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Regulatory Submission Expert
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Director of Supply Chain Excellence
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Director of EU Regulatory Strategy
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Lead Regulatory Affairs Strategist
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Financial Director
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Senior Marketing Director
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