Director, Global Regulatory Affairs - CMC

at  Genmab

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role
The project portfolio at Genmab is evolving, and we are therefore looking for a Director to join the Regulatory Affairs CMC team.
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.
The position is based in Copenhagen, Denmark and is hybrid.
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 guidances

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

Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on
our website
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• 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