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Regulatory Affairs Specialists - CMC  

Leo Pharma (company)

Posted on : 03 June 2017

Project Description

Regulatory Affairs Specialists - CMC

Do you want to make a difference in a challenging position?

At LEO Pharma, we are currently looking for two Regulatory Affairs Specialists with solid knowledge and experience working with life-cycle management (LCM) of the quality documentation for drug products and drug substances for both chemical and biological products.

Your job

As Regulatory Affairs CMC Specialist, you will be working with life-cycle management of the quality documentation for some of LEO Pharma s approved drug products and drug substances some of which are of biological origin. You will perform regulatory assessment of change control cases, prepare regulatory strategies for variation applications and participate in the preparation of the quality documentation for variation applications. You will also be involved in obtaining approvals in new markets and support renewal applications.

You will work in RA product teams where you in close cooperation with other Regulatory Affairs colleagues will plan and project manage variation submissions. You will be part of a cross-functional team, which have the responsibility to maintain the quality documentation and handle CMC-related issues for the drug products and drug substances.

You will also take part in the general activities in the department, including improving and implementing integrated regulatory business processes and share new Regulatory Intelligence knowledge.


We expect you to have:

  • a relevant scientific degree
  • 3 years+ experience from Regulatory Affairs within life-cycle management of approved products, preferably including maintenance of quality documentation for biological products
  • knowledge of regulatory requirements within life-cycle management in EU  preferably also in other major markets and countries outside EU
  • clear focus on agreed objectives, even when working with tight deadlines

Furthermore, you are:

  • a strong communicator
  • passionate and enthusiastic in your way of working
  • a strong and proactive team player who thrives on working independently in a matrix organisation in an international environment

About Regulatory Affairs

In RA we are responsible for global regulatory activities from early discovery throughout the life-cycle of our products in more than 100 countries world-wide. We work closely together with our colleagues across functions and with our affiliates, area offices, partners and consultants.

More than 100 people are currently part of RA which consists of six areas: Regulatory Affairs US, Regulatory Affairs Europe+, Regulatory Affairs International, Regulatory Affairs Projects, Regulatory Operations and Project Business Support. The vacant positions are placed in Regulatory CMC, which is part of Regulatory Operations.

Contact and application deadline

For further information, please contact Manager of Regulatory CMC DK, Marianne Bager telephone +45 41371160 or Head of Regulatory CMC, Mette M. Sonne, telephone +45 41889548.

Please submit your application no later than June 30, 2017.

We look forward to receiving your application.


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