(Associate) Director Regulatory Affairs Pharma

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 30 colleagues in Belgium, the Netherlands, the UK, Spain and Austria. Our customer portfolio spans the entire globe (Asia, US, Europe, Africa).

We are looking for an (Associate) Director Regulatory Affairs Pharma to join our UK team.

What do we expect from you as (Associate) Director Regulatory Affairs Pharma ?

• 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 international 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 and maintain personal contacts with regulatory agencies or professional associations.
• You assist in the preparation of proposals (e.g. researching new potential projects, determining activities required).
• 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 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, particularly in the review/generation of clinical documents .
• You have excellent written and verbal communication skills and proven negotiation 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 non-sense 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 Group offers you an attractive and competitive salary package , 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 can be yourself.
• In short … We stand for? JPEG : J oy in P artnership, going for the E xtra mile to G et 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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