Submission Manager - Camurus (Lund)
Toblor Consulting AB / Kemiingenjörsjobb / Lund
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hela Sverige 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 colleagues in a fantastic Regulatory Affairs team with good atmosphere, where the colleagues support and care for each other. Camurus is an innovative company currently expanding and establishing in new markets.
In this position you will report to VP Regulatory Affairs and be part of the Regulatory team, based at the headquarters in Lund. The team consists of ten colleagues working with regulatory affairs activities, covering all existing and potential Camurus markets. You will work in a deadline driven and international environment requiring a high level of change adaptation.
As Submission Manager, you will support and provide guidance related to regulatory operational submission management questions. The role is operational/tactical with emphasis on practical issues, rather than strategic. You will for example provide hands-on work to prepare documents to be submission ready and contribute to decisions regarding timelines of regulatory submissions. You will also be responsible for creating and managing submission plans and packages in line with overall regulatory strategy. In close cooperation with Regulatory Affairs Managers, you will set the plan, structure and timeline for regulatory submissions.
For the right candidate there will be great opportunities to grow within the role and take bigger responsibility.
Candidate profile
We are looking for a candidate with at least 3 years professional experience within Regulatory Affairs, preferably from a global submission team working with for example US and EU markets. This means you have good understanding of drug development processes and proficiency in relevant submission-related regulations and guidelines. Excellent communication and documentation skills (oral/written) in English is required, together with high level of MS Word skills. A strong merit will be knowledge in compiling and publishing tools.
To be successful in this role, you need a very structured and organised mindset with strong focus on details and time management. You are good at independently managing multiple ongoing projects. 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.
Camurus offers
This 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 not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. This position offers a fantastic opportunity to work in a competent and committed Regulatory team - where the laughter is never far away. Since this position is new to Camurus, you will have great opportunities to influence the ways of working. We also offer you an interesting journey being part of supporting a New Drug Application (NDA) to the US FDA.
Camurus has approximately 190 employees with the headquarters 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.
Camurus offers
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:
https://www.camurus.com/.We are looking forward to seeing your application!
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2023-09-10
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 7582565
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