CMC REGULATORY AFFAIRS MANAGER

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn.

Here is an opportunity to join a fantastic Regulatory Affairs team with a friendly, supportive atmosphere and committed and knowledgeable colleagues! We are looking for a temporary parental leave replacement for a period of 12 months, starting as soon as possible.

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 five 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.

You will work with lifecycle management and maintenance of our pharmaceutical products already on the market. In addition, you will support drug development and commercialization of new products. You will get the chance to work with different markets like EU, UK, AU, MENA and rest of the world.

The position is a 12 months temporary position.

The role:

• Lead and implement CMC submission strategies/activities for registered products, including life-cycle management plans.

• Manage maintenance activities for registered products, including regulatory impact assessment of CMC changes.

• Compilation, review and update of CMC-related documents for new submissions and post-approval submissions.

• Interact with internal and external regulatory stakeholders.

• Respond to CMC questions from Health Authorities.

• Provide CMC regulatory expertise in cross-functional project teams.

• Develop and improve processes and ways of working.

Your profile:

We are looking for a candidate with preferably 2+ years of professional Regulatory Affairs experience, working on pharmaceutical regulatory affairs activities. You have knowledge within the CMC regulatory area and in relevant regulatory-related regulations and guidelines. 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.

We offer:

This is a great time to join a highly dynamic company during an exciting phase of growth. The 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 maintaining existing products on different markets, but also supporting new market applications.

Our corporate culture is driven by the core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment.

Application:

This is an immediate, full-time employment opportunity. The application process is ongoing, so apply with your cv and cover letter as soon as possible, at the latest 7 April. Please note that we do not accept applications by e-mail.

Read more about how Camurus will process your personal data here.

Welcome with your application!