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GMP & Regulatory Affairs Coordinator

Genmab



GMP & Regulatory Affairs Coordinator

Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role

The CMC area of Genmab is growing and looking for a GMP & Regulatory Affairs Coordinator to join the team in Copenhagen.

The GMP & Regulatory Affairs Coordinator supports CMC with maintenance of the CMC SOPs, training modules and GMP system. In addition this individual supports the CMC writers with coordination and authoring of sections for INDs and replies to regulatory bodies.

The postion reports to VP CMC.

Responsibilities

You will be responsible for coordination of:

  • SOP updates,
  • Organizing training and training modules in CMC
  • Maintenance of CMC Operations GMP document system
  • Supporting CMC writers with IND authoring, updates and replies

Requirements

  • Master's degree or equivalent and a solid background 3 - 5 years from working in a similar role within a biotech/pharma company
  • In addition you have experience in authoring and reviewing CMC sections of regulatory files
  • It is expected that you have a proven track record of working in a GMP environment and understanding og development of biologics
  • Preferably with understanding of operational processes for all stages of development Ph I through Ph III

Moreover, you meet the following professional requirements:

  • Proven experience working in teams
  • Ability to work successfully under pressure in a fast-paced environment and with tight timelines
  • Ability to be proactive, enthusiastic and goal orientated
  • A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders
  • Strong communication skills - both oral and written

In case you have any questions, please feel free to reach out to Recruiter Jannie Jensen at jjn@genmab.com

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.

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Genmab - hurtigt overblik


Genmab
Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has three approved products in collaboration, a broad clinical and pre-clinical product pipeline and four proprietary next generation antibody technologies.

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Kalvebod Brygge 43
1560 København V
Logo: Genmab
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