QbD Group offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD.
Our Regulatory Affairs division supports customers throughout the entire regulatory lifecycle of their products, whether they are traditional pharmaceutical products, generic medicines, vaccines, biologicals, biosimilars, medical devices, IVDs or Advanced Therapy Medicinal Products (ATMP). Our RA division has a strong international presence with over 100 colleagues in Belgium, the Netherlands, the UK, Spain, Poland and Austria. Our customer portfolio spans the entire globe (Asia, US, Europe, Africa).
We are looking for a Consultant to join our Legal Representative Services team.
What do we expect from you as Consultant Legal Representative Services?
1) Correct and efficient execution of Legal Representative tasks and responsibilities, including but not limited to:
1. Providing support to clients to ensure their documentation packages are complete by providing guidance and advice on the documentation needed per respective country and by performing a high-level review of the documentation provided by the client.
2. Submit client application/notification packages to the respective Competent Authorities and/or Ethics Committees.
3. Daring to make decisions of which the outcome can't always be assessed, and only verifying major decisions with others (e.g. manager). Not putting off decisions. Presenting arguments in a clear and structured way and taking into