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Director, Global Regulatory Affairs - CMC
At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science.
The Role
The project portfolio at Genmab is evolving, and we are 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. This role offers an exciting and challenging opportunity in a dynamic, global company collaborating with talented and experienced colleagues in Regulatory Affairs as well as within Genmab’s CMC organization.
You will report to the Senior Director of Regulatory Affairs CMC and be part of a team consisting of 8 experienced and dedicated colleagues. The position is based in Copenhagen, Denmark and is hybrid.
Responsibilities
- 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 lifecycle management.
- Proficient communication in English (verbal and written).
Moreover, you meet the following personal requirements:
- Excellent collaboration and communication skills.
- Ability to thrive in cross functional teams.
- Ability to work independently and drive projects to successful outcomes.
- Positive attitude and ability to prioritize work in a fast-paced environment.
- Driven by achieving goals and dedicated to contributing to the overall success of Genmab.
- Enjoy fostering a collaborative team environment by offering support and sharing knowledge with colleagues.
About You
- Passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
- Bring rigor and excellence to all that you do.
- A generous collaborator who can work in teams with diverse backgrounds.
- Determined to do and be your best and take pride in enabling the best work of others on the team.
- Willing to grapple with the unknown and be innovative.
- Experience in a fast-growing, dynamic company (or a strong desire to).
- Work hard and are not afraid to have a little fun while doing 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.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its team to improve the lives of patients through innovative antibody therapeutics. For more than 20 years, our passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
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.
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