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CMC Regulatory Affairs Manager

Work in the CMC Regulatory Affairs area within an exciting and fast growing biotech company

Genmab has a robust pipeline of innovative human antibody therapeutics and a number of strategic partnerships are already in place with international blue chip companies. The company is continuing its positive growth and development, striving towards its goal of improving the lives of cancer patients with unmet medical needs.

In order to strengthen the Regulatory Affairs team, Genmab is looking for an experienced CMC Regulatory Affairs Manager who will be based in Copenhagen.

As CMC Regulatory Affairs Manager, you will be responsible for operational and strategic regulatory input with an emphasis on CMC matters to support worldwide development and commercialization of the Genmab pipeline. You will be part of the operational teams directing and coordinating international regulatory submissions supporting the conduct of clinical trials. Furthermore, you will be supporting marketing authorization submissions to EMA and other regulatory health authorities.

With direct report to Vice President – Head of Global Regulatory Affairs

The key responsibilities are to:

  • Develop and execute sound and robust global regulatory CMC strategies for Genmab biologic drug products at various stages of development
  • In collaboration with the Regulatory team, provide direction and guidance to the project development team to ensure high likelihood of regulatory approvals
  • Proactively, and in a timely manner, evaluate and communicate regulatory risks and challenges, and propose ways to mitigation to the projct team and senior management
  • Prepare and manage the regulatory CMC sections of clinical applications (IND and IMPD), Health Authority briefing packages, marketing applications in selected markets, and responses to agency requests
  • Update and maintain the CMC documentation submitted to Health Authorities to ensure compliance
  • Provide advice and guidance on EU, US, and selected WW regulatory legislation for CMC topics and initiatives as they apply to Genmab projects/products
  • Be a member of Project Task Force teams and ad hoc member of Project Core teams
  • Liaise and collaborate with Manufacturing and Quality Assurance groups within Genmab for CMC regulatory issues
  • Liaise with Authorities for CMC regulatory issues and represent Genmab at meetings and interactions with Health Authorities for CMC regulatory topics/issues
  • Contribute to establishing and administering internal regulatory policies and procedures to achieve best practices work processes including writing SOP’s
  • Collaborate with cross-functional peers to facilitate and optimize the product development and registration process including writing of regulatory documents
  • Stay abreast of newly issued regulatory laws and guidance as well as technical publications, articles, and abstracts in order to promptly identify possible impacts or improvements to product programs
  • Participate in professional and industry organizations to follow regulatory trends, influence development of regulations and guidance, and develop relationships to represent the interests of the company


You have experience with
the regulatory CMC area as well as a good understanding of compliance and biologics. You have experience working directly with global health agencies on regulatory matters. You have a successful track record in moving therapeutic products through various stages of development and approval as well as proven experience developing short- and long-term regulatory strategies to rapidly deliver innovative products to the market. You should be adept at formulating and driving strategy, tactically oriented in preparing and writing submissions, and be proficient in a hands-on role. You also have the ability to collaborate effectively with multiple functions including research, development, clinical, and quality.

You have a relevant university degree – preferably a Master of Science in Pharmacy, Engineering, or Chemistry.

You are a person who thrives on being challenged and working collaboratively. You have strong interpersonal skills and possess the abilty to communicate with other development staff in a fast-paced setting. You are comfortable in a dynamic environment in which priorities and drivers can change rapidly and you have the ability to think and manage strategically with attention to detail. You are pragmatic, robust, and able to stand firm. You have a high energy level and a passion and sense of urgency for developing important new medicines for devastating diseases.

Genmab offers a challenging position within Regulatory Affairs where the right candidate will get the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients. Genmab is an organization with a short chain of command, and as CMC Regulatory Affairs Manager, you will have the opportunity to influence your own work as well as your personal and professional development.

Travelling: 20 days/year

Domicile: Kalvebod Brygge

For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M +45 21 75 19 25. All applications must be in English and are treated confidentially.

 

Genmab strives to improve the lives of cancer patients by creating and developing innovative antibody therapeutics. With two marketed products and a robust pipeline of differentiated antibodies, Genmab is working to transform the treatment of cancer.

At Genmab, they are motivated by knowing that their work has the potential to make a real difference for cancer patients and their families. Their culture values innovation, determination, teamwork, and integrity. They work cross-functionally and internationally as one global team, while individuals and local teams have the autonomy to drive the development of innovative products and technologies that could provide next generation cancer treatments. 

Please refer to Genmab’s homepage www.genmab.com/careers for more information about working at Genmab.

Kontakt
Unique Human Capital A/S
cvr: 31502705

Stamholmen 157, 1. tv
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T +45 7020 6700
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Unique Human Capital Poland Sp. z o.o.
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01-211 Warszawa
Poland
T + 48 22 291 32 20