This position is open at our offices in Copenhagen, Denmark.
LINK Medical is searching for a Regulatory and Marketing Compliance Manager. Do you work in Regulatory Affairs and want to extend your qualifications to review promotional materials for pharmaceuticals? Do you know how to establish good and lasting relations with internal and external partners? We have this great job opportunity.
LINK Medical is searching for a Regulatory and Marketing Compliance Manager. Our company is growing, and the portfolio of cross-functional projects is increasing. As a 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 might require to be outsourced to clients 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, 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
- 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.
- Good knowledge of European pharmaceutical legislation and guidelines and experience with writing and reviewing regulatory submission documents.
- Fluent in Danish and English (both languages are required)
Personal characteristics
- Focuses on client needs and satisfaction
- Sets high standards for quality and quantity
- Works systematically and delivers on promises
- Takes initiative and is solution-oriented
- Team player with focus on collaboration and sharing of expertise
What LINK Medical offers
We offer an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given engaging assignments requiring efficient collaboration with industry partners, clinical and scientific teams and the regulatory authorities. We offer a competitive compensation and benefit scheme for all employees.
Contact information
If you would like to know more or have any questions about the position, please contact Director Regulatory, Lone Dyrby, +45 3135 3318, lone.dyrby@linkmedical.eu.
All applications are treated confidentially.
Last day for submitting your application: 6th of October 2023.
Please apply for the job by filling out the application below:
