Team Lead, Associate Director, Global Regulatory Affairs CMC
Team Lead, Associate Director, Global Regulatory Affairs CMC
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Job Description
At Genmab were committed to building extranotordinary 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
As our project portfolio at Genmab continues to grow we are expanding our team and seeking a Team Lead Associate Director to join the Regulatory Affairs CMC (RA CMC) this role you will lead a sub-team within RA CMC while also actively contributing to project work balancing leadership responsibilities with hands-on involvement in regulatory activities ensuring both strategic oversight and direct impact.
We offer an exciting and challenging opportunity in a dynamic global company where you will collaborate with talented and experienced colleagues in Regulatory Affairs and Genmabs CMC organization. Our team is strong and supportive fostering a culture of collaboration and trust making it a valued partner to the CMC organization.
The RA CMC team at Genmab consists of 11 experienced and dedicated colleagues. As part of our growth we are now looking for a Team Lead to guide a sub-team within RA CMC while also actively contributing to regulatory projects as a member of the broader RA CMC team.
This role is based in Copenhagen and reports directly to the Senior Director of RA CMC who is located in Denmark.
Responsibilities
The responsibilities of the role will include but are not limited to:
Lead mentor and develop team members to help them perform at their best fostering a high-performing and collaborative team environment.
Provide strategic direction and oversight for the sub-team within RA CMC ensuring alignment with broader regulatory and business objectives.
Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late-stage development as well as throughout the product lifecycle.
Support team members in navigating regulatory challenges and decision-making ensuring high-quality regulatory deliverables.
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.
Liaise and negotiate with global health authorities on RA CMC topics representing Genmab in meetings and interactions with health authorities.
Stay informed on evolving regulatory laws guidance and industry trends ensuring best practices are implemented within the team.
Requirements
Master of Science in pharmacy engineering or equivalent.
Minimum of 10 years of industry experience within RA CMC with a strong understanding of compliance and biologics.
Experience with leadership.
A track record in moving therapeutic products through various stages of development.
Experience with lifecycle management.
Proficiency in English communication (verbal and written).
Moreover you meet the following personal requirements:
You have strong leadership skills and can inspire and motivate others to achieve common goals.
You lead by example promoting accountability integrity and excellence in your work.
You are comfortable making decisions providing guidance and supporting team members in a dynamic environment.
You foster a culture of continuous learning coaching and professional development within the team.
You have excellent collaboration and communication skills.
You thrive when challenged and enjoy working in cross-functional teams.
You have a quality mindset and can prioritize your work in a fast-paced and changing environment.
You are result-oriented and committed to contributing to the overall success of Genmab.
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 youre 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 Genmabs 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.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice ().
Required Experience:
Exec
Employment Type
Full-Time
