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REGULATORY AFFAIRS SPECIALIST

Fertin Pharma A/S



Fertin Pharma has a solid background in the Nicotine Replacement Therapy (NRT) category developing and manufacturing nicotine gum primarily. However, as part of our diversification strategy we are expanding our activities in other categories and other pharmaceutical forms. Building on our long history as a B2B company we are engaging with new customers for both European, North American and international markets in addition to progressing development opportunities by ourselves.

In order to fuel this growth along with supporting our existing customers and their mature products we are looking for an experienced regulatory affairs specialist.

The Regulatory Affairs function is involved in all development projects and our specialists collaborate with specialists from other departments on strategy, documentation etc. We plan, coordinate and collaborate on establishing the CMC/Quality part of the regulatory dossier and are the important link to our regulatory counterparts at our customers.
We take lead in the process of responding to questions from the authorities and are an integrated part of life-cycle management activities post-approval.

Main Responsibilities:

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.

  • 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 take lead in life-cycle management activities for existing products/customers and may be also be involved in working with new customers that license some of Fertin’s own products
  • You will work with regulatory intelligence
  • You will bring your experience into discussing regulatory approaches, documentation requirements and optimising work processes

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, alternatively from another department where you have significant experience with preparing CMC/Quality documentation for regulatory dossiers
    • You are proactive, systematic and can establish and discuss a regulatory approach including risks and benefits for both life-cycle management activities as well as for issues during development
    • You use your experience and knowledge to ensure that our documentation is fit for purpose with the right level of detail and compliant with authority requirements
    • 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 position in a team where you will be able to influence the way we work and develop your competences
    • An opportunity to join a leading B2B pharma company undergoing change rooted in a successful journey within nicotine chewing gum and strong aspirations to grow beyond this
    • A possibility to work long-distance. Our experience during the recent COVID-19 period has taught us, that a great deal of the assignments in Regulatory Affairs can be solved on the distance, hence it is not an ultimate criteria that you live in the area around Vejle.

Send your cover letter and CV in English as soon as possible via the link below by September 30th 2020. Interviews will be conducted on an ongoing basis.

For further information please contact Senior Manager, Regulatory & Clinical Affairs Lise-Lotte Guldmann, e-mail: ligu@fertin.com, phone: 7215 1380.

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Fertin Pharma A/S - hurtigt overblik


Placering
Dandyvej 19
7100 Vejle
Logo: Fertin Pharma A/S
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