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Norgine Danmark A/S

Hospital Specialist Representative



Kirsten Walthers Vej 8a, 2500 København, Danmark

ID: 2151791
Indrykket for 76 dage siden


Do you have a passion for Regulatory Affairs? Would you like to apply this passion in a growing European Pharmaceutical company where patients truly matters to us? Then this role at Norgine is for you!

In this key role in our business, you will be responsible for preparing high quality documentation for straightforward regulatory submissions; liaising with relevant departments and ensuring that regulatory requirements for these submissions are met. You will communicate with regulatory authorities in order to expedite approval of these submissions with guidance or assistance as required.

Sounds interesting? Then read on…

In this role, you will liaise with relevant internal departments and external contacts to ensure regulatory requirements for all submissions are met and to communicate with regulatory authorities in order to expedite approval of submissions, both independently and as directed by line manage. you will also prepare and maintain, product labelling for appropriate markets in cooperation with local regulatory and commercial contacts, whilst resolving straightforward regulatory issues and to assist in the resolution of more complex issues.

At Norgine, we look for the following skills, exprience and knowledge in our Regulatory Affairs Executive:

  • Good university degree in a relevant life science subject or equivalent
  • Well-developed regulatory experience and general knowledge of worldwide regulatory requirements (including GMP, GLP and GCP)
  • A full strategic understanding of the drug development principles and processes
  • Experience in regulation of medical devices considered an advantage
  • Awareness of external regulatory environment
  • Demonstrates a good ability to analyse and summarise data
  • Focuses on customer needs, follows up on commitments and requests
  • Good interpersonal skills
  • Excellent verbal and written communication skills
  • Works cooperatively within a team
  • Able to work effectively without supervision, very good self-organisation skills
  • Excellent command of spoken and written English
  • Results-orientation
  • Reliable and motivated
  • Commitment to detail, thoroughness
  • Very good understanding of Microsoft Office (Word, Excel, PowerPoint)
  • Knowledge of more than one Nordic language would be considered as a advantage
  • Awareness, understanding and an ability to interpret the ICH guidelines relevant to his/her technical/functional responsibilities, specifically those related to developing a Target Product Profile and delivering a product at the end of the development process
  • Working experience and good knowledge of EU regulatory environments
  • If this resonates and is what you might be searching for, apply now!

    A recent acquisition by Goldman-Sachs, Norgine is a leading European
    specialist pharmaceutical company that has been bringing transformative
    medicines to patients for over a century. Our commitment to transforming
    people’s lives drives everything we do and our European experience, fully
    integrated infrastructure and exceptional partnership approach enables us to quickly
    apply creative solutions to bring life-changing medicines to patients that they
    may not otherwise be able to access. Norgine is proud to have helped 24 million
    patients around the world in and generated € million in net product
    sales, a growth of 10% over .
    Norgine has a direct presence in 16 European countries, as well as Australia and New
    Zealand. We also have a strong global network of partnerships in non-Norgine
    markets. We are a flexible and fully integrated pharmaceutical business, with
    manufacturing (Hengoed, Wales and Dreux, France), third party supply networks
    and significant product development capabilities, in addition to our sales and
    marketing infrastructure. This enables us to acquire, develop and commercialise
    specialist and innovative products that make a real difference to the lives of
    patients around the world. In December , the Private Equity business within
    Goldman Sachs Asset Management has completed its acquisition of a majority
    stake in the company. With Goldman Sachs Asset Management as its key
    partner, Norgine is strongly positioned to deliver on its mission of bringing
    transformative medicines to market while purposefully putting patients at the
    heart of its strategy.
    In , Norgine established Norgine Ventures, a complementary business which
    supports innovative healthcare companies through the provision of debt-like
    financing in Europe and the US. For more information, please .

    NORGINE and the sail logo are trademarks of the Norgine group of companies.

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