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Home - Global Regulatory Affairs Manager, Labelling

Global Regulatory Affairs Manager, Labelling

Global Regulatory Affairs Manager, Labelling
English

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 & womens health, urology & uro-oncology and gastroenterology & liver diseases, 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 a newly established Labelling team within Global Regulatory Affairs at Ferring. Joining the team now, you will be able to influence the future way of working in the department.

THE DEPARTMENT

The Labelling team currently consists of 3 regulatory product/project managers, based in Copenhagen. The team is part of the Global Regulatory Affairs Business Support department, also responsible for Medical Device Regulatory Affairs, Regulatory Compliance and Regulatory Information Management.

THE JOB

Reporting to the Director, Global Regulatory Business Support, your main responsibilities will be as listed below. You will be supporting or driving activities, depending on your level of experience:

Drive and coordinate the creation of company core labelling documents in close collaboration with subject matter experts as well as management of the EU SmPC and PIL for CP/MRP/DCP
Lead global labelling submission activities for assigned projects/products
Provide regulatory labelling expertise to cross-functional teams such as the Global Regulatory Project Teams, Product Teams and Launch Teams
Monitor implementation of labelling changes and manage the labelling deviation process in the Labelling Committee
Plan and/or participate in Health Authority meetings in relation to labelling activities
You will be working in an international environment and have interfaces with many different disciplines including other Regulatory disciplines, Global Clinical R&D, Global Pharmacovigilance, Product Supply and Ferring’s affiliates around the world.

YOUR QUALIFICATIONS

The ideal candidate holds a degree in life science or Pharmacy, with at least 3 years of experience in global regulatory affairs. Preferably the working experience includes regulatory labelling activities.

You have excellent administrative skills and are good at communicating verbally and in writing.

You must have a proactive mindset and a desire to continuously develop and find innovative solutions to regulatory challenges. In addition, you are well-organized and have the ability to plan, execute and meet deadlines. You have good negotiation skills and can deal with ambiguity. You are a true team player, an experienced user of IT (including MS Office), and are keen on working in a multicultural corporate environment.

ADDITIONAL INFORMATION

Further information about the position can be obtained from:

Director, Anne Neergaard Poulsen, Global Regulatory Affairs Business Support. Mobile: +45 28787558

Your application and CV in English should be sent as soon as possible but no later than 1st of October 2018, as we will be reviewing incoming applications on an on-going basis.

Location:
Ferring Denmark

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