CMC Regulatory Affairs Manager - Camurus (Lund)

at  TOBLOR Consulting

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.

AT CAMURUS YOU WILL GET THE OPPORTUNITY TO WORK WITH COMMITTED AND KNOWLEDGEABLE COLLEAGUES IN A FANTASTIC REGULATORY AFFAIRS TEAM WITH A FRIENDLY, SUPPORTIVE ATMOSPHERE. SINCE ONE OF OUR COLLEAGUES ARE TAKING ON NEW CHALLENGES INTERNALLY, WE ARE NOW LOOKING FOR ITS SUCCESSOR.

In this position you will be part of the CMC Regulatory Affairs team, in the global Regulatory Affairs organisation, at the headquarters in Lund. The team today consists of four colleagues working with CMC regulatory affairs activities, covering all Camurus’ products and projects. You will work in an international environment requiring a high level of flexibility.
This is a key position to support drug development, clinical trials and commercialization of new products, as well as maintaining products already on the market. You will get the chance to work with different markets like US, EU and rest of the world.

CANDIDATE PROFILE

We are looking for a candidate with at least 5 years of professional Regulatory Affairs experience, working on pharmaceutical regulatory affairs activities, including maintenance and life-cycle management activities for US and EU. You have profound knowledge within the CMC regulatory area and proficiency in relevant regulatory-related regulations and guidelines. It is an advantage if you are familiar with drug-device combination product regulations. Most probably,
you have a good understanding of drug development processes. You have a Bachelor or Master of Science degree.
Excellent communication and documentation skills (oral/written) in English are required, together with project management skills.
To be successful in this role, you need a structured and organised mindset together with strong focus on details and time management. Even though you are highly structured, you support change and can adapt to new conditions. We value a supportive and flexible “roll up the sleeves” attitude. You see solutions rather than problems and you possess a strong personal drive.

INFORMATION AND APPLICATION

For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Camurus, please visit: www.camurus.com/.
We are looking forward to seeing your application!

Please refer the Job description for details