CMC Regulatory Affairs Director

at  Camurus

Camurus is a Swedish science-led 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”.
Camurus has approximately 200 employees with the head office located in Lund. The corporate culture is driven by innovation, strong collaboration internally and externally, ownership, quality, and passion about realizing our ideas to achieve our patient-centric vision. For more information, visit .
At Camurus you will get the opportunity to work with committed and knowledgeable colleagues in a fantastic Regulatory Affairs team with a good, supportive atmosphere. Camurus is an innovative company currently expanding and establishing in new markets.
In this new position as CMC Regulatory Affairs Director you will be part of the global Regulatory Affairs organisation, and be leading the CMC Regulatory Affairs team, 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. You will spend your time on both line manager duties and operational CMC regulatory activities.

YOUR PROFILE:

We are looking for a candidate with at least 5 years of professional Regulatory Affairs experience, working on pharmaceutical regulatory affairs activities. Preferably you come from a global regulatory team working with US and EU. You have profound knowledge within the CMC regulatory area. This means you also have a good understanding of drug development processes and proficiency in relevant regulatory-related regulations and guidelines. 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 are a true leader with a genuine interest in people. You need a structured and organised mindset 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.

APPLICATION:

Camurus is partnering with TOBLOR Consulting for this recruitment. 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, , by uploading your CV and personal letter.
For more information about Camurus, please visit: .
We are looking forward to seeing your application

• Managerial duties.
• Develop and improve processes and ways of working.
• Responsible for CMC strategies for development projects and registered products, including life-cycle management plans.
• Lead and implement CMC submission strategies/activities.
• Prepare and lead Health Authority meetings for CMC regulatory matters.
• Compilation, review and update of CMC-related documents in clinical trial and marketing authorization applications.
• Represent and drive CMC-related activities in cross-functional collaboration.