Associate Consultant Legal Representative Services

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 an Associate Consultant to join our Legal Representative Services team.

1) Under supervision and guidance of more senior team members, correct and efficient execution of Legal Representative tasks and responsibilities, including but not limited to:

• 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.
• Actively seek feedback from more senior team members and use it to improve.
• Submit client application/notification packages to the respective Competent Authorities and/or Ethics Committees
  .
• Follow-up with client in case of questions/remarks from the National Competent Authorities and/or Ethics Committees.
• Submission of substantial modifications or study halt/termination/end to the National Competent Authorities.
• Support more senior team members when QbD Group acts as single point of contact for all communications from the National Competent Authorities and/or Ethics Committees with the sponsor.
• If reportable adverse events occur, cooperate with the sponsor and National Competent Authorities to ensure correct reporting is done in agreement with service-related procedures.
• Communicate with the Client, Competent Authorities and/or Ethics Committees in a correct, accurate, quality-minded and timely manner and in agreement with service-related procedures.
• Store client and project related documentation in an organised, accurate and quality-minded manner and in agreement with service-related procedures.

2) Within the role you must be able to take up some of the responsibilities associated with project management
, including but not limited to:

• Ensuring correct, efficient and timely execution of assigned tasks and responsibilities, in an independent, yet collaborative manner, without compromising on quality.
• Attend project related meetings (internal and external) or, under supervision and guidance of more senior team members, organise project related meetings (internal and external).
• Support the Legal Representative team in creating detailed project plans using company provided tools.
• Professionally liaise with colleagues as well as the client to communicate and resolve potential issues.

3)
As part of the Legal Representative Service team you must contribute to ensuring the team remains up to date of the submission requirements for both applications as well as notification of IVD performance evaluation studies to National Competent Authorities and/or Ethics Committees and support in ensuring the broader legal representative team is kept informed of changes and requirements
.

• You have a higher degree in life science or technology
• You have strong attention to detail
• You have good written and verbal communication skills
• You have good organizational skills and an analytical mindset
• You enjoy working in an international environment

A true QbD’er can be recognized by the following qualities:

• Resilient
  :
  Your strong and positive attitude helps you overcome any challenge
• Hungry for knowledge: You are always open to learning
• No non-sense mentality: you can be straightforward in a respectful way
• Innovative
  :
  You are constantly looking for new and better solutions
• (Not too) serious
  : your job is serious, but you don’t take yourself too…