Requirements: English
Company: QbD Group
Region: Mechelen , Flanders
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 30 colleagues in Belgium, the Netherlands, the UK, Spain and Austria. Our customer portfolio spans the entire globe (Asia, US, Europe, Africa).
We are looking for a Specialist to join our Authorised Representative Services team.
What do we expect from you as Specialist Authorised Representative Services?
1) Correct and efficient execution of Authorised Representative tasks and responsibilities, including but not limited to:
- Provide support to clients to ensure their documentation packages are complete by providing guidance and advice on the documentation needed for Europe, UK and/or Switzerland and by performing a high-level review of the documentation provided by the client.
- Submit notification packages to the respective Competent Authorities.
- Follow-up with client in case of questions/remarks from the National Competent Authorities.
- Submission of changes to the National Competent Authorities.
- Act as single point of contact for all communications from the National Competent Authorities with the legal manufacturer.
- Communicate with the Client and Competent Authorities 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:
- Ensure correct and efficient execution of assigned tasks and responsibilities, with minimal supervision and 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 Authorised Representative team in creating and maintaining 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 Authorised Representative Service team you must contribute to ensuring the team remains up to date of the requirements for notification of manufacturers, new devices or changes to existing devices to the National Competent Authorities (BE, UK and Swiss) and support in ensuring the broader authorised representative team is kept informed of changes and requirements.
Who are we looking for?
- You have a higher degree in life sciences or technology
- You have a first experience within the life sciences industry
- 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 QbDer 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 dont take yourself too serious.
Whats 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 were a knowledge-based company, youre 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 everyones contribution and celebrate achievements together
Our promise to you: