This position is open at our office in Copenhagen, Denmark.
LINK Medical is searching for a highly motivated full time Regulatory Manager at our office in Copenhagen, Denmark. Our company is growing, and the portfolio of cross-functional projects is increasing. As Regulatory Manager, you will work in close collaboration with members of internal and external project teams, with local and international projects and customers, and members of the Regulatory Group across the LINK Medical organization. The position might require working from clients’ offices in the greater Copenhagen area.
Your responsibilities will include, but not limited to, regulatory lifecycle management and development activities like:
- Regulatory and CMC advice to the product/project teams
- Develop timelines for regulatory activities and ensure execution
- Update databases and tracking tools to ensure projects and commitments are adhered to.
- Develop and/or review regulatory dossiers, product information and other relevant regulatory documents
- Translation of regulatory documents (Danish – English and vice versa).
- Liaison with regulatory authorities
- Contribution to the development of regulatory strategies for assigned product(s)/project(s)
- Compliance review of promotional materials
- Contribute to the continuous improvement and securing 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.
- MSc in pharmacy or equivalent life science.
- 2+ years of experience within regulatory affairs. Previous experience within the consultancy business would be an advantage.
- Experience within regulatory development projects and lifecycle management.
- Experience with Medical Device regulations would be an advantage.
- Experienced in writing and reviewing regulatory submission documents.
- Fluent in Danish (required) and English.
- Generally good IT skills and use of standard office tools. Knowledge in Veeva Vault and Microsoft Dynamics is preferred, but not required.
- You are structured with an eye for details but also having the ability to be pragmatic and keep the overview.
- You work independent and flexible.
- You are a team player with a consultancy mindset – a professional, advisory personality who is competent in creating and maintaining relationships.
- You take responsibility for your tasks and can work with ambitious timelines.
- You are result- and process-oriented and you have the ability and desire to do a difference for current and new clients.
- You have focus on achieving business goals.
LINK Medical offers
LINK Medical offers 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 in an international environment and values as honest and open communication are essential. 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.
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, firstname.lastname@example.org
All applications are treated confidentially.
Last day for application: 28th of February 2021. Applications will be processed continuously.
Please apply to the job by filling out the application below: