Manager/Senior Manager/Associate Director, Regulatory Affairs CMC
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.
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
The Role and Department
The project portfolio at Genmab is evolving and we are looking for more colleagues to join our Regulatory Affairs CMC (RA CMC) team.
Depending on previous experience we are looking for various levels i.e.. Manager/Senior Manager/Associate Director and you will be responsible for operational and strategic regulatory input related to CMC to support worldwide development and commercialization.
You will report to the Senior Director of RA CMC and be part of the RA CMC team consisting of 6 very experienced and dedicated colleagues.
The position is based in Copenhagen, Denmark.
Key Responsibilities include
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 at early stage and late stage development
In collaboration with the RA team, provide direction and guidance to the project development team
Evaluate and communicate regulatory risks and challenges
Prepare and manage the regulatory CMC documentation for clinical applications, marketing authorization applications, health authority briefing packages, and responses to information requests
Provide advice and guidance on EU, US and selected worldwide regulatory legislation for CMC topics
Liaise and negotiate with global health authorities on regulatory CMC topics and represent Genmab at meetings and interactions with health authorities
Collaborate with cross functional peers to facilitate and optimize product development
Life Cycle Management
Stay abreast with newly issued regulatory laws and guidances
Requirements
It is expected that you hold a Master of Science in pharmacy, engineering or equivalent
You have a minimum of 3 years of experience within the RA CMC Or CMC area for the Manager level position and at least +7 years for the Senior Manager/Associate Director positions
It is required that you have a good understanding of compliance and biologics This being from RA CMC and/or CMC, where you have gained a good understanding of the scientific and strategic requirements
A track record in moving therapeutic products through various stages of development.
Good communication skills in English (written and oral)
Moreover, you meet the following personal requirements:
As a person you thrive being challenged and working in cross functional teams
You have a quality mindset and are able to prioritize your work in a fast paced and changing environment
You have good interpersonal and communication skills
You are result- and goal-oriented and committed to contributing to the overall success of Genmab
The position is hybrid and located in Copenhagen
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
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
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 https://www.genmab.com/privacy.