Associate Director, Global Regulatory Affairs CMC

Associate Director, Global Regulatory Affairs CMC

Genmab

Copenhagen, Denmark

The Role

To support our growing portfolio of marketed products and their ongoing lifecycle management, Genmab is seeking an Associate Director to join the Regulatory Affairs CMC team.

In this role, you will provide strategic and operational regulatory CMC expertise across the global lifecycle of our commercialized products. You will contribute to long-term lifecycle planning and global regulatory alignment, while ensuring compliant and efficient post-approval maintenance and continued commercialization worldwide.

Responsibilities

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

• Develop and execute robust global regulatory CMC strategies for marketed biological products throughout their lifecycle;
• Collaborate with cross-functional colleagues to optimize lifecycle activities and ensure alignment across functions;
• Plan, review, and prepare CMC documentation for marketing authorization maintenance, post-approval variations, and health authority submissions;
• In collaboration with CMC, plan and prepare responses to health authority information requests;
• Provide advice and guidance on EU, US, and selected global regulatory legislation and guidance relevant to CMC;
• Evaluate and communicate regulatory risks, challenges, and strategic implications across the product lifecycle;
• Liaise with and negotiate with global health authorities on regulatory CMC topics, representing Genmab in meetings and interactions;
• Stay up to date on regulatory laws, guidances, and best practices relevant to post-approval lifecycle management.

Requirements

• Master of Science in pharmacy, engineering or equivalent;
• Minimum 5-10 years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics;
• A track record in moving therapeutic products through various stages of development;
• Experience with lifecycle management;
• Proficient communication in English (verbal and written).

Moreover, you meet the following personal requirements:

• You have excellent collaboration and communication skills;
• You thrive being challenged and working in cross functional teams;
• You are able to work independently with an ability to drive projects to successful outcomes;
• You have a quality mindset and are able to prioritize your work in a fast paced and changing environment;
• You are result-oriented and committed to contributing to the overall success of Genmab;
• You enjoy fostering a collaborative team environment by offering support and sharing knowledge with your colleagues.