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Hjem - Node - Principal Regulatory CMC Specialist with biological experience

Principal Regulatory CMC Specialist with biological experience

Principal Regulatory CMC Specialist with biological experience
Engelsk

Do you want to help LEO take the next leap within biological products?

LEO Pharma has embarked on a very exciting journey to become the world’s preferred dermatology care partner. Part of making this come true is an increased and prioritised focus within biological substances and products. And that is why we need you. Based on your knowledge of regulatory requirements across the EU, the US and Japan you will become a key contributor in our efforts to bring new solutions to patients – and you will do it working in projects with highly skilled and dedicated colleagues in a matrix organisation.

Strategic CMC bio expert in cross functional project teams with global focus
As Principal Regulatory Specialist your overall focus is contribute to bringing products to the market by facilitating smooth approvals of Marketing Authorisation Applications. You will unfold your skills in cross-functional teams where you will provide strategic and operational regulatory CMC input for biological development projects. As such, you will create results via a close dialogue with team members, affiliates and stakeholders. Your primary tasks will be to:

  • Provide strategic and operational regulatory CMC input for biological development projects
  • Participate in preparing global regulatory strategies and CMC strategies for biological products in development
  • Identify documentation needed for simultaneous submissions in the major markets worldwide
  • Coordinate the regulatory authoring and review process during the compilation of the quality module for the Marketing Authorisations
  • Stay up to date on regulations and requirements across relevant markets

+10 years’ of regulatory experience within biological substances and products

You have a university degree within natural science and at least 10 years’ of regulatory experience from the pharmaceutical industry and/or from a medicinal agency. As one of our new bio experts you must especially bring solid knowledge within development and registration of biological substances and products as well as orphan drugs. This includes regulatory requirements and solid experience from working across the three major areas EU, US and Japan. Your career has also provided you with experience from preparation of CMC documentation for regulatory submissions including electronic submissions.

As you will be working in projects, you must be very good at planning, prioritising and keeping a clear focus on agreed objectives – also when working with tight deadlines. You must be at strong and proactive team player that thrives on working independently and with enthusiasm in a matrix organisation.

As part of various project teams you will need your open minded and pragmatic attitude including your ability to perform in an international environment. You can move things forward in a positive and constructive way based on your ability to bring your own ideas to the table and at the same time listen to your colleagues’ expertise and opinions. This also takes very good communication including the ability to explain complex information to people without your profound regulatory expertise.

Regulatory CMC – your new team

You will join 12 highly skilled regulatory professionals in our Regulatory CMC department based at the LEO Pharma Headquarters in Ballerup, Denmark. We share a common dedication of finding smart solutions to complex challenges. Our perspective is global, and all our communication is in English. We believe that people in balance create the best results, and we prioritise a sound work life balance.

We are part of Regulatory Affairs counting more than 100 colleagues across six main areas. RA is responsible for global regulatory activities from early discovery throughout the life cycle of our products in more than 100 countries worldwide.

Further information and application deadline

In case you have further questions about this position, please contact Manager Marianne Bager at +454137 1160.

Deadline for submitting your application is May 8th 2018.

We look forward to receiving your application.

Apply for job


About LEO Pharma 
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. 
Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. 
LEO Pharma is headquartered in Denmark and employs around 4,800 people worldwide. 
For more information, visit www.leo-pharma.com.

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