13 Jan

Senior Project Manager Regulatory Affairs Focus Team Ledige Stillinger på Leo Pharma København

Stilling
Senior Project Manager Regulatory Affairs Focus Team
Selskab
Leo Pharma
Beliggenhed
København D84
Er åbningsdato
13 Jan, 2018 30+ days ago

Leo Pharma København presserende behov efter position for Senior Project Manager Regulatory Affairs Focus Team. Læs denne jobannonce grundigt før ansøger om jobbet. Der er nogle kvalifikationer, erfaringer og kvalifikationsbehov, at arbejdsgiverne kræver. Er din karriere historie passer disse krav? Sørg for at du forstår den rolle, du søger, og at det er egnet til dine evner og kvalifikationer.

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Senior Project Manager Regulatory Affairs Focus Team Ledige Stillinger på Leo Pharma København Detaljer Job:

Do you want to be part of delivering LEO Pharma’s R&D portfolio?

If you have several years of regulatory experience across the non-clinical and clinical areas, preferably within biologics, and you are looking for an opportunity to be part of a new and very exciting journey, this is it! A vital part of this journey is founded by strengthening the regulatory competencies in the biologic field. And that is why we need you. You will get the chance to personally impact the regulatory strategies and deliverables for key development projects and by this positively influence the goal of bringing innovative treatments to patients with skin diseases all over the world.

LEO has entered into the exciting field of biologics In the last few years LEO has developed from being a company focusing on development of topical treatments to now also driving a portfolio of biologics. This requires some new skills and competencies to be added to our already strong LEO team.

As Senior Regulatory Project Manager in our Regulatory Affairs Focus Team you will chair cross-departmental RA focus team(s) 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 development 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 – in collaboration with other regulatory functions e.g. Submission Management covering e.g.:
    • CTA’s, INDs, AgSRs, PIP, BLA
  • 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 including regulatory responsibility for documents like IBs, non-clinical and clinical protocols, reports and regulatory summaries and overviews
  • Representing RA in cross-functional clinical study teams.
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 - in particular 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 global regulatory documentation, especially in the non-clinical and clinical area. At the same time you are a strong strategic thinker.

You enjoy working globally and have experience working with other cultures. You have the communication and stakeholder management skills needed to create regulatory awareness. 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 7 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.


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