Vacancy RA Officer – Copenhagen
For a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries, we are looking for a Regulatory Affairs Officer. The organisation has a global infrastructure that is strategically located to support the needs of their customers. They operate in 40 countries and has around 12.000 employees worldwide with HQ in Belgium.
As the new RA Officer, you will be responsible for legal tracking, vigilance, interpretation, and concluding on necessary action regarding the new and updated legislation affecting the company’s business. You ensure that the business is correctly informed on the latest requirements and upcoming changes in the Danish and EU regulation. Next to that, the Regulatory Affairs Officer for Denmark will also support the Regulatory Affairs Nordics upon request. You will analyse Danish and EU regulatory requirements and interpret regulatory acts, including changes, and you ensure that they are communicated through the organisation.
In cooperation with stakeholders, you draft and define instructions with appropriate conformity actions for the business. You follow up on local legal requirements and legislation, and you are responsible for the contact with Danish authorities and participate in inspections, declarations, reporting, and license requests. You investigate queries with Danish authorities and you are accountable for obtaining, maintaining, and renewing local licenses to operate. You communicate and report to RA manager at HQ on all local activities such as inspections, updates in legislation and license requirements. You will also be responsible for developing or conducting employee regulatory trainings.
The right candidate ideally has the below mentioned competencies:
- A bachelor’s degree in applied science with a focus on Industrial Chemistry, Biomedical science, Biochemistry or Biotechnology or other relevant degree
- At least 5 years’ experience in regulatory affairs in the European jurisdiction
- Fluent in oral and written English and Danish
- A comprehensive understanding of legal requirements
- Experience in Lab Supply Pharma / Chemicals or equivalent experience.
- Proficiency in Microsoft Office tools and SAP (ERP) or other ERP system
- Customer centricity with advanced communication skills
- Open minded and team player in a multicultural environment
- Adaptive, flexible, and change-oriented
- Knowledge about data analysis and systems
The organisation offers you:
- The opportunity to be part of an upcoming and dynamic company in a challenging role
- The company offers you a permanent contract with an attractive salary package including a bonus, accident insurance, and health insurance
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Nicklas Smed Poulsen
Associate Recruiter | Nordics
+45 89 88 26 70