Principal Consultant Regulatory Affairs Pharma

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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 a Principal Consultant Regulatory Affairs Pharma? 

  • You provide a full range of regulatory consulting services in the development, registration and post-licensing activities of pharmaceutical products.
  • You are a Subject Matter Expert (SME) in the development phase (scientific advice, orphan drug designations, paediatric investigation plans) providing guidance to the QbD team across projects (training and mentoring).
  • You deliver projects on time and to a high quality.
  • You manage activities with minimal supervision and in an independent manner.
  • You interact professionally at multiple levels within a client organization.
  • 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.
  • You understand the primary functions of product development, microbiology, toxicology, clinical research, manufacturing and quality assurance. 
  • You have significant regulatory affairs experience including a successful track record in the development and registration of medicinal products within Europe. 
  • You have excellent written and verbal communication skills and 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:
    • Resilient: Your strong and positive attitude helps you overcome any challenge
    • Hungry for knowledge: You are always open to learning
    • No BS 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!

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