Regulatory Affairs Manager Nordic

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development - Regulatory Affairs, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

In the role Regulatory Affairs Manager Nordic the main purpose is to support the Head of Regulatory Affairs Nordic, to ensure that Marketing Authorisations and clinical trials are maintained in compliance with national requirement in the Nordic region and act as deputy for the Head of Regulatory Affairs Nordic. You will be working in our Nordic affiliate with close collaboration with the colleagues in Global Regulatory Affairs in our Head quarter in Aachen, Germany. This role is a limited assignment of 1 year with a possibility of extension to a permanent. The job is located in our Copenhagen office in Ørestad, with the possibility to work from home in agreement with the functional manager.  

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

•    To ensure submission and approval of regulatory applications to health authorities, such as Marketing Authorisation, variation, renewal and Clinical trial applications. 
•    To ensure that marketed products at all times are fulfilling the requirements of the local authorities including the actual labelling on the pack and in the package insert.
•    To interact with local authorities to support product approval and compliance and ensure that enquiries from local authorities are handled in a serious and timely manner.
•    To provide updated realistic timelines to the local Organisation for the approval and availability of new products and relevant changes of existing products (e.g. new indications, line extensions, reformulations). 
•    To ensure that updated local legislation and guidelines is available and interpreted for the use of project teams and other relevant GRT employees.
•    Ensures that an overview of the registration status for all products is maintained in the Nordic, including the tracking of all submissions and commitments.
•    To ensure that relevant processes are described in SOPs or other structured documents, and reviewed and updated accordingly.
•    Ensures the regulatory aspects review of the company product related materials (e.g. promotional, shortened SmPC).
 

What you'll bing to the table

To make the most of this role and truly thrive, you should have:

•    Scientific university degree (e.g. pharmacist, biological sciences, chemistry or comparable discipline).
•    Relevant experience in the pharmaceutical industry
•    Fluent in at least one Nordic language and business English language skills
•    Strong communication skills 
•    Microsoft based and good IT/system competence 
•    Very structured and attention-to-detail working style 
•    Ability to stay focused when multiple tasks are handled, and focus on details, as well as holding a high level overview.
•    Ability to work across a matrix organisation. 
•    Flexible, proactive, open working style, eager to learn, develop and supportive of training 
•    Taking ownership and embracing change
•    “Can do” mentality and enthusiastic attitude
 

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"If you want to work for a company that is passionate about changing lives for the better, this is the opportunity you’ve been waiting for. At Grünenthal, we join forces to make an impact and innovation is our passion. Our talented and committed people collaborate together across teams, functions and locations to make progress toward our vision of a world free of pain. Finally, we are proud to have the recognition obtained by Great Place to Work in Denmark. Join us today, and discover the difference you can make. " Michlawi Sara, the Hiring Manager