Director, Global Regulatory Affairs - CMC

Genmab

Copenhagen, Denmark

You will be responsible for operational and strategic regulatory CMC input to support worldwide development and commercialization. We can offer an exciting and challenging role in a dynamic, global company collaborating with talented and experienced colleagues in Regulatory Affairs as well as within Genmab’s CMC organization. Our Regulatory Affairs CMC team is robust and supportive, fostering a culture of collaboration and mutual support, and the team is a highly trusted partner to the CMC organization.

You will report to the Senior Director of Regulatory Affairs CMC and be part of the Regulatory Affairs CMC team consisting of 8 experienced and dedicated colleagues.

Responsibilities

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

Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle;
Collaborate with cross functional peers to facilitate and optimize product development;
Plan, review and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages;
In collaboration with CMC, plan and prepare responses to health authority information requests;
Plan and prepare post-approval applications;
Provide advice and guidance on EU, US and selected worldwide regulatory legislation for CMC topics;
Evaluate and communicate regulatory risks and challenges;
Liaise and negotiate with global health authorities on regulatory CMC topics and represent Genmab at meetings and interactions with health authorities;
Remain informed on regulatory laws and guidance.

Requirements

Master of Science in pharmacy, engineering or equivalent;
Minimum of 12 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 preparation of BLAs and 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 positive attitude and are able to prioritize your work in a fast paced and changing environment;
You are driven by achieving goals and dedicated to contributing to the overall success of Genmab;
You enjoy fostering a collaborative team environment by offering support and sharing knowledge with your colleagues.

About You

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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