Associate Director, Global Regulatory Affairs - CMC

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Director/Associate 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 therefore looking for a Director/Associate 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.

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

• 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 8+ 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 preferably experience with lifecycle management.
• Proficient communication in English (verbal and written).

Moreover, you meet the following personal requirements:

• Excellent collaboration and communication skills.
• Ability to thrive being challenged and working in cross-functional teams.
• Able to work independently with an ability to drive projects to successful outcomes.
• Quality mindset and ability to prioritize work in a fast-paced and changing environment.
• Result-oriented and committed 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.
• Not afraid to grapple with the unknown and be innovative.
• Experience working in a fast-growing, dynamic company (or a strong desire to).
• 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.

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.

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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