Regulatory Affairs Manager

Back Regulatory Affairs Manager

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 and supportive colleagues. Camurus is an innovative company currently expanding and establishing in new markets.

In this position you will be part of the Regulatory team, based at the headquarters in Lund. The team today 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 flexibility.

This is a key position to support the 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 lead critical regulatory activities, ensuring compliance and facilitating effective communication with health authorities. For the right candidate there will be great opportunities to grow within the role and take bigger responsibility.

Your responsibility:

• Maintaining core labelling, preparing and maintaining local labelling.

• Regulatory submissions and deliverables to drug development and life cycle management, including maintenance activities.

• Contributing and leading health authority interactions.

• Monitoring regulatory intelligence information on a regular basis.

• Represent Regulatory Affairs (RA) in the cross-functional teams and drive the regulatory agenda, raise RA concerns and opportunities.

Candidate profile:

We are looking for a candidate with at least 5 years professional experience, working on pharmaceutical regulatory affairs activities, preferably from a global RA team working with development projects for US and EU markets. This means you have 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 is required, together with project management skills.

To be successful in this role, you need a structured and organised mindset with strong focus on details and time management. You are good at independently managing multiple ongoing projects, but at the same time you enjoy working in a team. 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 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 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 work in a competent and committed Regulatory team – 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 product on different markets. You will work in a broad role, and you will learn a lot!

Camurus has 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 realizing ideas to achieve a patient-centric vision.

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: camurus.com.

We are looking forward to seeing your application!

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På Camurus drivs vi av att, genom innovativa medicinska produkter, förbättra livskvaliteten för patienter med svåra och kroniska sjukdomar.