Regulatory and Clinical Affairs Specialist

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Vejle

Regulatory and Clinical Affairs Specialist


Fertin Pharma is the world's leading B2B supplier of nicotine replacement therapy (NRT) chewing gum and specializes in developing and producing nicotine chewing gum. Furthermore, we have an expanding business both within medicated chewing gum but also within other delivery systems into both NRT and other therapeutic areas. With a unique range of product platforms and an innovative and global profile, Fertin Pharma engages in successful partnerships with leading pharmaceutical companies. Fertin Pharma is a private equity and family owned pharmaceutical company based in Vejle, Denmark.

As part of an ambitious growth plan Fertin Pharma continuously strive to improve the footprint across the world. Fertin Pharma aims to obtain market authorizations mainly in collaboration with pharmaceutical companies or as own portfolio ready for licensing. In order to fuel this growth along with supporting our existing customers and their mature products we seek an experienced regulatory and clinical affairs specialist.

The job:


  • You will work in development projects, where you will be expected to propose the best regulatory approach
  • You will plan, coordinate and collaborate on establishing the CMC/Quality part of the regulatory dossier and you are the important link to our regulatory counterparts at our customers
  • You will be part of the small team responsible for planning and coordinating our clinical studies and you handle the necessary documentation related to this
  • You will be responsible for Fertin Pharma’s pharmacovigilance system (the QPPV role is outsourced)
  • You will work with regulatory and clinical intelligence
  • You will bring your experience into discussing regulatory approaches, documentation requirements and optimizing work processes

Your main responsibilities will depend on your experience and interests, but you can expect it to encompass activities across all types of activities handled by the department


Qualifications:

    • You hold a M.Sc. in pharmacy, biology or similar.
    • Your will preferably have experience from a position in regulatory affairs working with the CMC/quality aspects
    • You have experience with carrying out or coordinating clinical studies, ideally bioequivalence studies.


  • You deliver on your tasks in a structured and dedicated manner and thrive in a fast-paced environment with many different stakeholders
      • You have good communication skills and you are fluent in English.


    We offer:

      • An opportunity to be a part of our ambitious growth strategy focusing on both maintaining and growing the core business and to diversify our product portfolio into new categories
      • A socially and academically based work environment, where we meet each other with confidence and provide you with responsibility
      • Employment as soon as possible.


    For further information please contact Senior Manager, Regulatory & Clinical Affairs Lise-Lotte Guldmann, e-mail: [email protected], phone: +45 4132 9946

    Application Deadline: Tuesday, February 25, 2020


    Information og data

    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Vejle.

    Jobbet er oprettet på vores service den 23.12.2019, men kan have været deaktiveret og genaktiveret igen.

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    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Øvrige
    • Vejle
    • Tirsdag den 25. februar 2020
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