CMC Regulatory Affairs Manager
Toblor Consulting AB / Biomedicinjobb / Lund
2024-09-26
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hela Sverige Camurusis 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 proprietaryFluidCrystal 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.
AtCamurusyou will get the opportunity to work with committed and knowledgeable colleagues in a fantastic Regulatory Affairs teamwith 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.
Your responsibility:
Lead and implement CMC submission strategies/activities for development projects and registered products, including maintenance and life-cycle management plans.
Compilation, review and update of CMC-related documents in clinical trial and marketing authorization applications.
Prepare for Health Authority meetings for CMC regulatory matters.
Respond to CMC questions from Health Authorities.
Manage maintenance activities for registered products, including regulatory impact assessment of CMC changes and compilation of post-approval submissions.
Provide CMC regulatory expertise in cross-functional project teams.
Represent and drive CMC-related activities in cross-functional collaboration.
Develop and improve processes and ways of working.
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.
Camurus offersThis is a great time to join a highly dynamic company during an exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market - and the ambitions are to continue in the same way. With a diversified project portfolio in different stages, the commercial potential is considerable. This position offers a fantastic opportunity to join a competent and committed CMC Regulatory Affairs team - where we care for each other, and where the laughter is never far away. We offer you an interesting journey being part of supporting new market applications (NDA, MAA), but also maintaining existing products on different markets.
Camurushas approximately 230 employees with the headquarters located in Lund. The corporate culture is driven by innovation, strong collaboration internally and externally, ownership,quality, and passion about realizingideasto achieve a patient-centric vision.
Information and applicationFor 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!
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2025-03-15
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Toblor Consulting AB (org.nr 559244-5547),
http://www.toblor.se Arbetsplats Toblor Consulting
Kontakt Tobias Lorentzon
tobias@toblor.se 0735-11 10 60 Jobbnummer 8923438