LEO Pharma

Head of Regulatory Compliance

Can you head a new team and take lead in building global alignment?

 

 If you have solid experience across Regulatory Affairs (RA) and people management, and you are looking for an opportunity to make a difference far beyond the average, this is it. LEO Pharma has set the very ambitious goal to become the world’s preferred dermatology care partner. As part of this we are taking our total organisation and operation to the next level, and that is why we need you to establish global compliance in Regulatory Affairs. Exciting challenges and major impact are guaranteed in this position.

 

360 degrees responsibility from strategy to implementation and optimisations

As part of our overall strategy we has decided to simplify our RA QMS set-up and at the same time strengthen the global alignment of RA processes, SOP’s and the like. Basically, your job is to make this happen. Together with your team of 3 people and process responsible colleagues across the RA organisation you will harvest the best of existing SOP’s and when necessary build new processes. Your primary tasks will be to:

 

  • Establish the new team – roles, focus points etc.
  • Develop a new strategy and plan for establishing global regulatory compliance
  • Lead, motivate and coach your team – including RA specific coaching and guidance
  • Establish collaboration and knowledge sharing with key stakeholders within RA and across LEO
  • Develop and implement simplified RA QMS set-up and new, global SOP’s, Working Instructions etc.
  • Develop and implement adequate process training of RA persons, globally
  • Ensure inspection readiness within RA, globally

 You will be based at the LEO Pharma headquarters in Ballerup, Greater Copenhagen.

 

Manager experience and solid knowledge within RA

You have Master’s degree within natural science and a minimum of 5 years’ experience from working hands on with RA and/or QA in an international pharma company. This is backed by several years’ experience as people manager. Your previous career has provided you with profound understanding of the regulatory framework and procedures in a global perspective. Additionally, you have solid experience from working with quality management, e.g. via managing a Quality Management System. As such, you understand how RA contributes to the drug development process including life-cycle management.

 As manager for a newly established team you will need entrepreneurial spirit and a strong drive for results. To succeed, you must be able to make others commit to your agenda – solid stakeholder management. This takes good communication skills including the ability to listen and involve people affected by your plans – across professional, geographical and cultural borders. At the same time you are fully capable of prioritising and making decisions.

 

Contact

It will not be possible to contact Marianne Toft in the following period: 21 July 2018 - 6 August 2018.

 

We look forward to receiving your application.

 

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Region:

  • Region Hovedstaden
  • Region Sjælland

Job type:

Permanent

Working hours:

Full-time

Application deadline:

06/08/2018

Location:

Ballerup, Greater Copenhagen

Contacts:

Marianne Toft

Mobile: +45 4089 2238

Company homepage:

http://www.leopharma.com

Office address: