Job Summary

About Us Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other critical human diseases.

The Role Genmab is looking for an experienced and passionate Global/EU RA Leader to be a part of our Global Regulatory Affairs organization.

As a regulatory leader, your responsibilities will range from developing global and EU regulatory strategies to advancing Genmab’s portfolio of development pipeline candidate drugs. As Global/EU RA Leader you will provide strategic input and ensure operational execution of global/EU submission activities.

The RA Leader will be communicating directly with global health authorities as the primary contact for the company for assigned programs.

The Global RA/EU Leader will be part of a regulatory team reporting to VP, Head of Global Regulatory Affairs.

This position is in our Copenhagen, Denmark office.

Key Accountabilities The key responsibilities include but are not limited to:

• Acting as the global regulatory leader (GRL) or assigned projects
• In collaboration with regional regulatory leaders, be responsible for the development of innovative, robust global strategies and ensure efficient and effective execution of such strategies for pipeline assets
• Also act as the EU regulatory leader (EU RL) for an assigned project. Represent the EU GRA perspective and be accountable to develop and maintain EU aspects of regulatory strategy documents
• Evaluate regulatory risk and recommend mitigation strategies to ensure optimal organizational success
• Represent GRA in global Compound Development Teams (CDT) to successfully meet project deliverables
• Lead the strategic development of briefing materials and prepare teams for global health authority meetings
• Participate in the development of and assessthe appropriateness of submission documentation to support successful IND/CTAs as well as BLAs/MAAs
• Evaluate various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, PRIME, Fast Track, accelerated/conditional approval, compassionate use, paediatric plans) and ensure application of these
• Work to develop Company Core Data Sheet and Summary of Product Characteristics
• Consult with senior management to create and communicate regulatory strategies and advice for products and programs
• Monitor and assess global and EU regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products
• Interact with the global health agencies and EMA for assigned projects (through a vendor when applicable).
• Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders
• Participate in the review of and comment on regulatory guidance as relevant
• As assigned by management, provide due diligence assessment of licensing/acquisition opportunities

Skills & Experience

• You hold a master’s degree in Science, Pharmacy, Engineering or equivalent.
• Minimum of 5 years of hands-on industry experience within Regulatory Affairs (Oncology experience preferred)
• Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA)
• Strong strategic skills including the ability to make complex decisions and willingness to support challenging positions
• Good knowledge and understanding of global and EU regulations
• Solid knowledge and understanding of complicated medical and scientific subject matter as well as evolving regulatory policy and guidance
• Excellent communication skills in English (written and oral)

Moreover, you meet the following personal requirement

• As a person, you thrive and can work well within cross-functional teams
• You use appropriate interpersonal styles and techniques and can modify behaviour to gain acceptance of ideas or plans
• You have excellent interpersonal and communication skills You are result- and goal-oriented and committed to contributing to the overall success of Genmab

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