Associate Consultant RA & Publishing

Associate Consultant RA & Publishing

Location
:
QbD UK - hybrid
Type
:
Full-time

We are looking for a motivated and curious Associate Consultant to join our Regulatory Affairs & Publishing team.

This is an exciting opportunity for someone at the beginning of their career who is interested in the pharmaceutical and life sciences industry and wants to develop their knowledge of Regulatory Affairs, regulatory submissions and dossier publishing.

We are looking for someone with a strong scientific foundation, attention to detail, a willingness to learn, and an interest in developing a career in regulatory consulting.

You will work closely with experienced colleagues and gradually take on more responsibility as your knowledge and confidence grow.

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts:Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.

Build a meaningful career:As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued.

As an Associate Consultant, you will support the Regulatory Affairs & Publishing team with day-to-day activities and gradually develop your ability to manage tasks independently.

Your responsibilities may include:

• Supporting the preparation and organisation of regulatory submission documents.
• Assisting with the compilation, formatting, and quality checking of regulatory documentation.
• Supporting the preparation and maintenance of eCTD dossiers under the guidance of experienced colleagues.
• Assisting with regulatory submissions and related administrative activities.
• Helping to maintain submission trackers, project documentation, and regulatory records.
• Supporting the preparation and review of documents such as Module 1 content and product information.
• Performing document checks to ensure that information is complete, accurate, and consistent.
• Supporting the team with publishing activities and electronic submission processes.
• Conducting basic research into regulatory requirements and guidelines.
• Helping to monitor regulatory changes and sharing relevant information with the team.
• Supporting client projects and internal Regulatory Affairs activities.
• Working collaboratively with colleagues across Regulatory Affairs and other life sciences functions.

As you gain experience, you will have the opportunity to take ownership of more complex tasks and contribute more independently to client projects.

• A university degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Biomedical Sciences, or a related scientific discipline.
• No previous Regulatory Affairs experience is required. Relevant internships, university projects, placements, or experience in the pharmaceutical/life sciences industry are welcome but not essential.
• Knowledge of CTD/eCTD, EU pharmaceutical legislation, regulatory procedures, or electronic submission systems would be an advantage, but is not required.
• An interest in pharmaceutical Regulatory Affairs and regulatory submissions.
• A willingness and ability to learn new concepts, regulations, and processes.
• Good attention to detail and a careful approach to working with documents and data.
• Good organisational skills and the ability to manage several tasks with appropriate guidance.
• Basic analytical and problem-solving skills.
• Good written and verbal…