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.
What do we expect from you as (Associate) Director Regulatory Affairs?
- You are part of the UK management team, leading development and growth of the company.
- You provide a full range of regulatory consulting services (strategy and writing) with an emphasis on clinical documents (overviews, briefing packages, orphan drug designations, paediatric investigation plans).
- You deliver complex projects on time and to a high quality
- You are a source of regulatory expertise in the development, registration and post-licensing activities of pharmaceutical products.
- You have line management responsibility and provide guidance to the QbD team across projects (training, supervising, mentoring, reviewing).
- You interact professionally at multiple levels within a client organization.
- You continue to build a network of industry colleagues. You develop and maintain personal contacts with regulatory agencies or professional associations to build confidence in and enhance the reputation of QbD.
- You assist in the preparation of proposals (e.g. researching new potential projects, determining activities required).
Who are we looking for?
- You have a university degree in life science.
- You have sound knowledge of European 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 within Europe, in particular a strong background in the review/generation of clinical documents (overviews, briefing packages, orphan drug designations, paediatric investigation plans).
- 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:
- 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 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 done!
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!