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Senior RA Project Manager – Regulatory Affairs Focus Team  

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Posted on : 05 April 2017

Project Description

Senior RA Project Manager – Regulatory Affairs Focus Team

Do you want to be part of and impact LEO’s new overall approach to Life Cycle Management?

If you have some years of regulatory experience across non-clinical and clinical content and you are looking for a job with the opportunity to personally influence the regulatory support and value creation in a leading international company, this is your chance. You will enter LEO Pharma in the most interesting period of time. Everywhere you turn, exciting projects are taking place and Life Cycle Management (LCM) is one. LEO Pharma is about to significantly change the LCM approach and you will become an important part of making this business critical operation a success.

Development of new setup and project execution from strategies to evaluation

Never change a winning team the phrase goes. However, in an R&D company you sometimes can forget to pay the necessary full attention to your solid old successes. But that is about to change. With a new setup, a team of truly dedicated professionals and full focus we will bring new vitality into existing and old products as well as products that has not yet unfolded their true potential.

As Senior Regulatory Project Manager in our Regulatory Affairs Focus Team you will chair cross-departmental RA focus teams with members from RA CMC, labelling, Submission Management and colleagues from our global affiliates. With you as the main driver the teams will prepare, drive and implement regulatory strategies into Life Cycle Management projects. Your key responsibilities will be to:

  • Lead regulatory focus team(s) – ensure business perspective across functions and high regulatory quality
  • Set direction, motivate, building trust and ensure commitment among team members
  • Drive submissions to approval – in collaboration with other regulatory functions e.g. Submission Management covering:
    • MAA’s and NDA’s, Variations, Fulfilment of commitments, AgSR, renewals and annual reports etc.
  • Ensure issue management if plan is deviated
  • Ensure best use of available resources
  • Provide RA input to clinical and non-clinical strategies and documentation
  • Plan and drive authority interactions
  • Act as non-clinical or clinical RA subject matter expert

Your many international contacts will give you the opportunity for major influence and impact across teams and stakeholders and provide you with a thorough understanding of the business.

+5 years’ experience within RA – especially in the non-clinical and clinical area

You have a natural science degree at minimum a master’s level and at least 5 years’ experience within RA. Your career has provided you with solid knowledge of regulatory documentation, especially in the non-clinical and clinical area. At the same time you are a strong strategic thinker and you can see the exciting potential in putting new life into LCM.

You enjoy working globally and you have the communication and stakeholder management skills needed to create regulatory awareness in a cross-functional setting. Related to this you can tailor your messages to the receivers of the information at hand. To succeed, you must also be able to lead, inspire and motivate members of your teams that do not report to you.

About Regulatory Affairs Focus Team

You will join an established team of 9 RA Project Managers. Our goal is to build a culture centred on knowledge sharing, helpfulness and the ability to learn from hands-on experiences. We see you as an important contributor in making this vision come through. We are based at the LEO headquarters in Ballerup, Greater Copenhagen. We are part of the Global RA organisation counting approx. 150 people across the globe that shares the ambition to deliver top quality across projects and assignments.

 

We look forward to receiving your application.