CMC Regulatory Specialist
Job SummaryAbout us
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 diseasesThe role
Genmab is looking for an experienced CMC Regulatory Specialist to strengthen the Regulatory Affairs team in Copenhagen.
As RA Specialist at Genmab, you will be responsible for operational and strategic regulatory input on CMC matters to support worldwide development and commercialization. You will be part of the operational teams directing and coordinating international regulatory submissions supporting the conduct of the clinical trials.
The RA Specialist will be part of a team of 9 reporting to VP, Head of Global Regulatory Affairs.Key Accountabilities
- Develop and execute sound and robust global regulatory CMC strategies for biologic drug products at early 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 regulatory CMC sections of clinical applications (IND and IMPD), health authority briefing packages, and responses to information 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.
- Member of Project task force teams and ad hoc member of project core teams
- Liaise with authorities for CMC regulatory issues and represent at meetings and interactions with health authorities.
- Collaborate with cross functional peers to facilitate and optimize product development.
- Stay abreast with newly issued regulatory laws and guidance.
- You hold a master’s degree in science, Pharmacy, Engineering or equivalent
- 5 years’ experience with the regulatory CMC area and a good understanding of compliance and biologics.
- 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
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.
If you would like additional information about this position before applying using the link, please contact Recruiter Jannie Jensen (email@example.com)
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To learn more about Genmab, you can visit our website: http://www.genmab.com/