
📍 Location: Hybrid-Spain
🕓 Type: Full-time
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).
· 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
· You provide a full range of high-quality regulatory consulting services (strategy and writing).
· You manage complex regulatory projects with multiple stakeholders.
· You act as strategic lead overseeing project scope, timelines, and budgets.
· You lead and coordinate activities within multidisciplinary teams.
· You delegate tasks and supervise the work of team members.
· You are a trusted regulatory expert across product development and life-cycle activities.
· You interact professionally and effectively with senior management and client leadership.
· You build and maintain a strong network of client, industry, and regulatory relationships to build confidence in and enhance the reputation of QbD Group.
· You support business development and proposal preparation.
· You have significant regulatory affairs experience including a successful track record in the development and/or registration and/or life-cycle maintenance of medicinal products.
· You have a university degree in life science.
· You have sound knowledge of European/UK/US pharmaceutical regulations and guidelines.
· You have significant regulatory affairs experience including a successful track record in the development, registration and life-cycle maintenance of medicinal products.
· You have excellent written and verbal communication skills and proven negotiation skills. You can establish strong connections with clients, regulators, management and colleagues.
· 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:
o Resilient: Your strong and positive attitude helps you overcome any challenge
o Hungry for knowledge: You are always open to learning
o No non-sense mentality: you can be straightforward in a respectful way
o Innovative: You are constantly looking for new and better solutions
o (Not too) serious: your job is serious, but you don’t take yourself too serious
Our culture is driven by values If this sounds like you, you’ll fit right in:
You’re resilient and tackle challenges with a positive mindset
You’re curious and always up for learning something new
You have a no non-sense approach honest, clear, respectful
You’re innovative and bring ideas, not just opinions
And above all, you’re serious about your work, but not too serious about yourself
We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.
We believe in JPEG:
Joy. Partnership. Going the Extra Mile. Getting Things Done.
You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.
📩 Interested? Let’s talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.
The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a global company with over 700 high-qualified employees.
Our experienced team serves the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise we have built in these areas. The services we offer fall under the following divisions:
• Regulatory Affairs: We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle.
• Clinical: We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy.
• Qualification and Validation: We guarantee that products meet quality demands and comply with regulation through the qualification and validation of your processes, equipment, and software.
• Quality Assurance: We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP (Qualified Person) activities.
• Quality Control: Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products.
• Software solutions: Cloud-based and pre-validated Quality Management Software built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use (IFU).
• Go to market: We help you launch your product to market by providing marketing and communication services, business development support and sales strategy.
Take the next step in your career journey