Principal Regulatory Consultant
il y a 1 mois
Table of Contents
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 14 years and won the 2018 Queen’s Award for Enterprise in International Trade.
What do we expect from you as a Principal Regulatory Consultant?
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.
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 organisational 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 complete salary package We invest in sustainable careers and meaningful connections We are a knowledge based company You’ll work for an international award winning company 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 doneInterested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family
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