This position is open at our offices in Copenhagen, Denmark.
LINK Medical is searching for a a highly motivated Regulatory and Marketing Compliance Manager. As Regulatory and Marketing Compliance Manager, you will work in close collaboration with clients and partners and with dedicated members of the Regulatory and Marketing Compliance teams across the LINK Medical organization. You will play a crucial role in providing qualified regulatory and marketing compliance support to our clients and partners.
The position may require working from clients’ offices in the greater Copenhagen area.
Responsibilities
- Compliance review of promotional and non-promotional materials and submission to the Danish Ethical Committee for the Pharmaceutical Industry
- Translation of regulatory documents (Danish – English)
- Regulatory life cycle management activities e.g., review and update product information, review and preparation of regulatory dossiers (incl. IND/IMPDs), provide regulatory advice, prepare regulatory strategies for submissions
- Liaison with regulatory authorities
- Contribute to the continuous improvement and securing of best practices within LINK Medical
- You will work with clients and projects/products, where the need for high-quality regulatory guidance and efficient operational implementation is important
Desired qualifications
- MSc in pharmacy or equivalent
- You have 2+ years of experience with regulatory affairs in the pharmaceutical industry. Previous experience within the consultancy business would be an advantage
- Ideally, but not necessarily, in addition to pharmaceuticals, you have regulatory experience with medical devices and food supplements. You have a good knowledge of European pharmaceutical legislation and guidelines and experience with writing and reviewing regulatory submission documents according to those guidances
- Fluent in Danish and English (both languages are required)
LINK Medical offers
LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. You will be given meaningful tasks requiring efficient collaboration between industry, regulatory and scientific teams, and the authorities. Besides a great working environment with dedicated and supporting colleagues, we also offer a competitive compensation and benefit scheme for all employees.
Contact Information
If you would like to know more or if you have any questions about the position, please contact Director, Regulatory Affairs: Lone Dyrby, +45 3135 3318, lone.dyrby@linkmedical.eu
All applications are treated confidentially and will be processed continuously.
Please apply for the job by filling out the application below:
