Regulatory Affairs Manager
Camurus is 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
Regulatory Affairs Manager
Join our journey in delivering better treatments
In this position you will report to the Head of Regulatory Affairs and be part of the Regulatory Affairs team working with lifecycle management and maintenance of our pharmaceutical products.
As Regulatory Affairs Manager you will be responsible for preparing and coordinating regulatory submissions such as new submissions, post-approval submissions and clinical trial applications. You will be an important member in the project team. You will also be responsible for interacting with Regulatory Authorities, maintaining core labelling and local labelling components and will be coordinating and project leading these activities. Regulatory compliance reviews will also be part of your tasks.
To be successful in this position you have a Science BSc or MSc, or similar university degree. You have as a minimum experience of working with operational EU regulatory activities for late-stage development projects.
You are enthusiastic with a strong drive and have a flexible mindset. You have excellent oral and written communication skills in English. You are motivated by working both independently and in a team in a dynamic environment. You have excellent project management skills, enjoy handling multiple tasks and are used to a high workload from time to time. You have a solution-oriented mindset. You are also enthusiastic to develop yourself within global early and late-stage drug development.
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 combination of local and international work environment and corporate culture, with the possibility for individual development and growth.
Camurus has approximately 125 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 on +46 46 286 39 18.
The application process is ongoing, so apply as soon as possible but no later than 13 December.
Read more about how Camurus will process your personal details here .