Manager, Global Regulatory Affairs, Strategy

Manager, Global Regulatory Affairs, Strategy

Genmab

Copenhagen, Denmark

In this role, the candidate will support the Global Regulatory Lead and/or Regional Regulatory Lead in the preparation of regulatory documentation and submissions to health authorities. The candidate will work in close collaboration with the Global Regulatory Lead and/or Regional Regulatory Lead for US.

Responsibilities

The responsibilities of the role will include, but is not limited to:

• Support the Global/Regional Regulatory Lead with preparation of regulatory documents, e.g. meeting requests, briefing documents, orphan drug designations, breakthrough therapy designation requests, response documents, module 1 documents etc.
• In collaboration with the Global/Regional Regulatory Lead, prepare or oversee preparation of regulatory submissions to health authorities, including management and oversight of timely input and delivery of documentation to meet deadlines for regulatory submissions.
• In collaboration with the Global/Regional Regulatory lead, evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.
• Support Global/Regional Regulatory Lead to assess global and US regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
• Follow all correspondence with the health authorities and ensure archiving and tracking.
• Proactively and in a timely manner, evaluate and communicate to the project team and management regulatory risks and challenges, and propose ways of mitigation.
• Maintain an updated knowledge of regulatory topics and regulations and provide regulatory input and recommendations to the project team and management
• Support the Global/Regional Regulatory Lead with preparations for health authority meetings and participate in health authority meetings, as applicable.
• Maintenance/operational regulatory work such as compiling and submission of amendments, DSURs and IB updates.

Requirements

• A minimum of bachelor’s degree or equivalent in scientific discipline or health-related field.
• Minimum of 3 years of experience in Regulatory Affairs.
• Experience in coordination of support to regulatory activities.
• Experience maintaining and tracking critical regulatory documentation in EDMS.

Moreover, you meet the following personal requirements:

• Organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Must have attention to detail and be able to solve problems with some supervision.
• Demonstrate robust teamwork by providing support with troubleshooting and resolving issues that arise within submission activities.
• You have a quality mind set and able to prioritize your work in a fast paced and changing environment.
• You are result- and goal-oriented and committed to contributing to the overall success of Genmab.

About You

• You are genuinely passionate about our purpose.
• You bring precision and excellence to all that you do.
• You believe in our rooted-in-science approach to problem-solving.
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds.
• You take pride in enabling the best work of others on the team.
• You can 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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