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Global Regulatory Affairs Associate (maternity cover)

Ferring Pharmaceuticals A/S



Driven by research and a passion for science, Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive medicines & women’s health, urology & uro-oncology and gastroenterology, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us.

We are seeking a new colleague to the Global Regulatory Affairs, Clinical and Non-Clinical area at Ferring. Would you like to join us in a maternity cover as Global Regulatory Affairs Associate?

THE JOB
Your main responsibilities will be as follows:

  • Ensuring compilation, submission and approvals of CTAs and INDs for all clinical trial related regulatory activities as well as maintaining these throughout the product development phases
  • Performing review of clinical trial documentation e.g. IB, DSUR, clinical trial protocol and report and represent regulatory in clinical trial team meetings
  • Managing specific parts of the labelling activities and ensuring compilation, submission and approvals of Clinical and Non-Clinical variations worldwide including compilation of Module 1 documents
  • Handling documents in the electronic document management system and managing updates and maintenance of the clinical trial management systems
  • Supporting compilation, submission and approvals of NDAs and MAAs in the US, Europe, Japan, China and other countries worldwide in collaboration with local regulatory colleagues
  • Member of Global Regulatory Project Teams for assigned projects and working together with a global regulatory team in preparing global regulatory strategies, identifying and managing regulatory risks, developing competitive labels, preparing road-maps for global regulatory submissions and coordinating regulatory activities in collaboration with relevant team members.

You will report to the Vice President and work closely with the Global Regulatory Affairs Leads.

YOUR QUALIFICATIONS
The ideal candidate holds a degree in Life Science or Pharmacy preferably with interest in or experience from working with clinical trials and other clinical regulatory activities.

You must have a proactive approach combined with the ability to plan and execute regulatory submissions and this also includes good judgment and decision-making skills. You are a true team player with a positive mind-set and you are keen on working in an international corporate environment.

Excellent verbal and written communication skills in English are important.

YOUR NEW TEAM
You will join the Global Regulatory Affairs, Clinical and Non-Clinical area which supports all global projects and life cycle management of marketed products which includes market expansions or product extensions or updates worldwide from regulatory Clinical, Non-Clinical and Labelling perspective. The area is also providing oversight of new regulatory intelligence developments and input to evaluation of external innovation.

CONTACT AND APPLICATION
Please send your application and CV no later than 17 August 2020

. If you have any questions, you are very welcome to contact (from 17 July to 4 August) Lise Laurbjerg Nielsen, Global Regulatory Portfolio Lead on mobile: +45 2878 7816 and (from 5 to 17 August) Lene Melchiorsen, Vice President on +45 2878 7680.

Ferring Pharmaceuticals is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists working to break new land to help people live better lives. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines.

As a privately-owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the world’s leading company within reproductive medicine and women’s health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at ferring.com

Location:

Ferring Denmark

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Ansøgningsfrist d. 17.08.2020
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Ferring Pharmaceuticals A/S - hurtigt overblik


Ferring Pharmaceuticals A/S
Ferring Pharmaceuticals A/S
Ferring is a research-driven, specialty biopharmaceutical group committed to helping people build healthy families and live better lives. Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.

Placering
Kay Fiskers Plads 11
2300 København S
Logo: Ferring Pharmaceuticals A/S
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