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CMC Regulatory Affairs Manager

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CMC Regulatory Affairs Manager

Camurus is a Swedish research-based pharmaceutical company committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal ® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”. For more information, visit camurus.com. 

We are strengthening our organization and recruiting a

CMC Regulatory Affairs Manager

In this position you will report to the Vice President Regulatory Affairs and be part of a Regulatory Affairs team. As CMC Regulatory Affairs Manager you will be responsible for CMC regulatory compliance and documentation for Camurus development projects and commercial products. You will also be a member of a project team working with CMC development activities. You will guide project teams in regulated processes, e.g. specification setting, stability program design and trending, quality by design, design control and risk assessment.

Candidate profile 
To be successful in this position you have at least a Master’s degree in Science, or similar university degree, and extensive experience of working with Pharmaceutical Development within the CMC and Regulatory area.

You are familiar with ICH, FDA, CHMP guidelines, and pharmacopoeias. It is an advantage if you are familiar with medical device/drug-device combination product regulations.

You are enthusiastic with a strong drive and have a flexible and solution-oriented mindset and work approach. You are motivated by working both independently and in a team in a dynamic environment. You enjoy handling multiple tasks and are used to a high workload from time to time. You have excellent oral and written communication skills in English.

The opportunity for you 
This is a great time to join a highly dynamic company during a very exciting phase of growth.  The position offers a dynamic international work environment and corporate culture, with the possibility for individual development and growth.  
 
Camurus has approximately 150 employees with the head office located in Lund. The corporate culture is driven by innovation, strong collaboration internally and externally, ownership by everyone, quality, and passion about realizing our ideas and goals.  
 
If you have any questions about the position, do not hesitate to contact Annette Mattsson, Vice President Regulatory Affairs, annette.mattssonatcamurus.com

The application process is ongoing, so apply as soon as possible, and we will be reviewing incoming applications on an ongoing basis. 

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CMC Regulatory Affairs Manager

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