You are a Belgium-qualified lawyer with minimum around 5 years of experience in Regulatory / Life Sciences.
You are fluent in French, Dutch and English.
Osborne Clarke is an award-winning international legal practice. Over the past few years, they have grown rapidly, with 25 offices around the world, and they are proud to say that their influence and impact can now be applied almost anywhere. The core sectors they work in all thrive on innovation: Tech, Media ²and Comms, Energy and Utilities, Financial Services, Retail and Consumer, Life Sciences and Healthcare, Real Estate, Workforce Solutions and Transport and Automotive.
The firm’s sector teams include lawyers from all legal disciplines, effortlessly blending expertise, insight and enthusiasm. Crucially, the firm thinks sector first, organising themselves around the current affairs and future challenges of the industries they serve, rather than traditional legal practice areas. It helps keep the firm one step ahead.
You will be part of and further develop the Regulatory / Life Sciences practice of Osborne Clarke.
Expertise is required in the following areas:
- Marketing authorisation/CE marking, and reimbursement of medicines.
- Regulation governing medical devices.
- Bolar and research exemption in Belgium;
- R&D, Consortium, and other IP collaboration.
- Clinical trials (CRO, authorisations, submissions, regulatory approvals etc.).
- Production and Manufacturing.
- Distribution and advertising relating to medicines and healthcare products, vigilance and recalls.
- Compliance programs.
- License agreements and strategic collaborations (together with the IP team).
- Issues relating to Digital Health, sample sourcing, patient sourcing (together with the data privacy team).
- Assistance before disciplinary organs in proceedings on the publicity for medicines (together with our commercial team).
- Assistance of biotech, pharmaceutical and medical devices companies on issues of advertisements, benefits, advantages promised (together with our commercial team).
- Belgian market entry procedures and conditions and pricing/reimbursement for pharmaceutical products and medical device (together with our commercial team).
- You are a Belgium-qualified lawyer with excellent academic credentials.
- You have minimum around 5 years of experience at a reputable law firm and are specialised in the Regulatory / Life Sciences area.
- You speak fluently French, Dutch and English. Any other language is an asset.
- You have strong communication and relational skills. You have an open, unprejudiced and international view.
- You are assertive, self-confident and a true team player, and at the same time you are able to work autonomously.
- You are open-minded, flexible and stress resistant.
You will be able to work in a truly international, stimulating and dynamic environment with motivated and enthusiastic colleagues, direct client contacts, and high-profile cases for companies operating in the Life Sciences sector.
The firm relies on a very professional working environment with all necessary support, which will enable you to concentrate on the high-level legal work.