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:

• 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.

• Submit client application/notification packages to the respective Competent Authorities and/or Ethics Committees.

• 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 account the opinions of others. Adapting arguments and communication style to the target audience. Intervening promptly when an urgent problem arises.

• 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.

• Act 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.

• Supervise and guide (coach) more junior team members. Offer active help and support to colleagues to complete their tasks and achieve results. Match tasks to the capabilities of each colleague. Gives honest and constructive feedback and makes others feel involved

• In case of problems, coming up with practical, workable solutions and translating them into a concrete action plan. Escalating issues when needed.

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

• Ensuring correct, efficient and timely execution of assigned tasks and responsibilities, with minimal supervision and in an independent, yet collaborative manner, without compromising on quality.

• Organising project related meetings (internal and external).

• Creating detailed project plans using company provided tools.

• Efficient management of projects, defining the scope, understanding project risks, assigning team members to specific tasks, managing team members and monitoring project deliverables, timelines, and budget.

• Professionally liaise with colleagues as well as the client to communicate and resolve potential issues.

• Act as project manager for some projects and as such monitor progress, time spent versus budget as well as money spent versus budget. Approve project associated incoming invoices associated to costs incurred and ensure accuracy of all outgoing invoices. Escalate where necessary.

3) You are responsible for service-related intelligence gathering and sharing, this includes but is not limited to:

• Monitoring and tracking submission requirements for both applications as well as notifications of IVD performance evaluation studies to National Competent Authorities and/or Ethics Committees.

• Supporting and assisting with the collection, maintenance and sharing of legal representative subject specific information to achieve team and company objectives.

• Ensuring the legal representative 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.

• Presenting at and/or participating to Conferences (internal and external). You represent and enforce the Qarad brand and QbD Group outside the company.

• Supporting members within the organisation with Legal Representative specific questions and acting as a subject matter expert and point of reference

4) Provide support to the Business, including but not limited to:

• Collaborating when required with internal Shared Services (e.g., Marketing, Finance, HR etc.).

• Collaborating with Sales and Business Development for the further expansion of our Legal Representative services by supporting with client calls or visits in which you act with commercial flair and interacting professionally at multiple levels within a client organization

Who are we looking for?

• You have a higher degree in life science or technology

• You have relevant experience in IVD, MD or biotech

• You have relevant experience in regulatory submissions

• You have relevant experience in working with multiple clients

• You have strong attention to detail

• You have strong 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 serious.

What’s in it for you?

• QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.

• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.

• As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.

• Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

Our promise to you:

• As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

• Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.

• In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done!
  

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!