The UK team of the international QbD group is a specialist regulatory and pharmacovigilance consultancy company. Our services consist in providing consultation throughout product development, regulatory approval, market launch, and into life cycle management. We have been offering support to life science companies for 15 years. 

What do we expect from you as Consultant Regulatory Affairs?

• You provide a range of regulatory writing services with supervision of senior team members with an emphasis on clinical documents (clinical trial applications, scientific briefing packages, orphan drug designations, paediatric investigation plans) with a focus on European and UK procedures.
• You deliver projects on time and to a high quality.
• You assist senior team members with their projects. 
• 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).  
• You develop and maintain regulatory skills and knowledge necessary to ensure effective support to clients.
• You monitor change in guidance/legislation in designated areas and informs the team.
• You build a network of industry colleagues and professional associations.
• You complete basic job related responsibilities e.g. maintenance of personal training record, timesheets, project archiving.
• You are able to commute to our headquarters in Chalgrove (Oxford area) for onsite working 2 days per week.

Who are we looking for?

• You have a university degree in life science or chemistry.
• You have general knowledge of European/UK pharmaceutical regulations and guidelines.
• You have a first relevant regulatory affairs experience.
• You have 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 nonsense 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 seriously.

What’s in it for you?  

• QbD 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!