Nordic-Baltic Regulatory Affairs Contractor
An internationally leading pharmaceutical company is seeking to recruit a Regulatory Affairs Contractor to their office in Stockholm. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.
The Regulatory Affairs Contractor will provide regulatory strategy and support for the company product portfolio, primarily for Sweden, but also across the Nordic-Baltic region at large. This will be a contract role, lasting 3 months in either a full-time or part-time capacity.
- Acting as the interface between the Swedish affiliate and European and Global RA, ensuring conformance to national and EU legislation.
- Communicating with national regulatory authority (MPA) and regulatory institutions.
- Acting as the primary contact with the Swedish national health authority (MPA) - in national (phase of) procedures and post-approval for the Swedish product portfolio, including the HA liaison regarding field corrective actions/direct healthcare professional communications, risk minimisation measures or supply constraints.
- Submitting applications to national authorities in Sweden for products approved in the national procedure and for the national phase for products approved through MRP and DCP.
- Ensuring timely responses to incoming authority requests including timely notification of approvals according to company SOPs.
- Maintaining labeling information to internal and external partners.
- Providing consolidated feedback regarding the text translation (in Swedish) from the relevant functions in the affiliate to the EU Regulatory Strategists/Global Labelling team.
- Managing artwork - centralized, MRP/DCP, and national products; reviewing and approving artworks.
- Liaising with the marketing and commercial teams to ensure that all local product information used are up to date.
- Providing collaborative support for commercial teams.
- Ensuring regulatory compliance in country in accordance with local regulations and company SOPs.
Skills and Requirements:
- Bachelor's degree required.
- Demonstrable regulatory affairs experience, particularly in freelance work.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sigrid Jorgensen at +44 203 856 9337 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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