Consultant Regulatory Affairs Pharma Regulatory Affairs • • Hybrid Remote

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 Consultant Regulatory Affairs Pharma to join our team.

What do we expect from you as a Consultant Regulatory Affairs Pharma?

1. You provide a range of regulatory writing services with supervision of senior team members, focusing on clinical documents (clinical trial applications, scientific briefing packages, orphan drug designations, paediatric investigation plans), mainly for European and UK procedures.
2. You deliver projects on time and with high quality.
3. You assist senior team members with their projects.
4. You provide QC functions within the QbD team (e.g., translations of product information compared to templates; clinical and nonclinical overviews compared to source data).
5. You develop and maintain regulatory skills and knowledge to support clients effectively.
6. You monitor changes in guidance/legislation in designated areas and inform the team.
7. You build a network of industry colleagues and professional associations.
8. You complete basic job-related responsibilities such as maintaining personal training records, timesheets, and project archiving.

Who are we looking for?

1. You have a university degree in life sciences or chemistry.
2. You have general knowledge of European/UK pharmaceutical regulations and guidelines.
3. You have some relevant regulatory affairs experience.
4. You pay attention to detail.
5. You have good written and verbal communication skills.
6. You possess good organizational skills and an analytical mindset.
7. You enjoy working in an international environment.

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

1. Resilient: Your strong and positive attitude helps you overcome challenges.
2. Hungry for knowledge: You are always eager to learn.
3. No non-sense mentality: You are straightforward but respectful.
4. Innovative: You constantly seek new and better solutions.
5. Not too serious: You take your job seriously but don’t take yourself too seriously.

What’s in it for you?

• QbD Group offers an attractive, competitive salary package tailored to individual needs, considering legal requirements and local laws.
• Join us to build a sustainable career with job security and meaningful connections.
• As a knowledge-based company, you will embark on continuous learning and development.
• Be part of our global success story. We value everyone’s contribution and celebrate achievements together.

Our promise to you:

• As an ambitious and pioneering company, we aim to offer the best environment for you to thrive within the life sciences.
• We strive to create a joyful community where you can be yourself, because growth happens best when we grow together as individuals.
• In short: JPEG — Joy in Partnership, going the Extra mile to Get things done!

If you’re interested, send us your CV and motivation letter. Who knows, you might soon join our QbD family!

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