Consultant Regulatory Affairs Pharma Regulatory Affairs • • Hybrid Remote

TRIUM Clinical Consulting NV; Cataluña; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the life sciences sector is seeking a Consultant Regulatory Affairs Pharma to provide regulatory writing services and support senior team members. The role involves ensuring compliance with European and UK regulations while delivering high-quality projects on time. Ideal candidates will have a university degree in life sciences or chemistry and relevant experience in regulatory affairs. Join a dynamic team that values continuous learning and offers an attractive salary package.

Servicios

Attractive and competitive salary package

Continuous learning and development

Job security and meaningful connections

Formación

• Relevant regulatory affairs experience required.
• General knowledge of European/UK pharmaceutical regulations.

Responsabilidades

• Provide regulatory writing services focusing on clinical documents.
• Assist senior team members with projects and provide QC functions.
• Monitor changes in guidance/legislation.

Conocimientos

Attention to Detail

Communication

Organizational Skills

Analytical Mindset

Educación

University Degree in Life Sciences or Chemistry

Descripción del empleo

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 a Consultant Regulatory Affairs Pharma to join our team.

What do we expect from you as a Consultant Regulatory Affairs Pharma?

1. You provide a range of regulatory writing services with supervision of senior team members, focusing on clinical documents (clinical trial applications, scientific briefing packages, orphan drug designations, paediatric investigation plans), primarily for European and UK procedures.
2. You deliver projects on time and with high quality.
3. You assist senior team members with their projects.
4. You provide QC functions within the QbD team (e.g., translations of product information compared to templates; clinical and nonclinical overviews compared to source data).
5. You develop and maintain regulatory skills and knowledge to support clients effectively.
6. You monitor changes in guidance/legislation in designated areas and inform the team.
7. You build a network of industry colleagues and professional associations.
8. You complete basic job-related responsibilities such as maintaining personal training records, timesheets, and project archiving.

Who are we looking for?

• You hold a university degree in life sciences or chemistry.
• You have a general knowledge of European/UK pharmaceutical regulations and guidelines.
• You have some relevant regulatory affairs experience.
• You pay attention to detail.
• You possess good written and verbal communication 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 challenges.
• Hungry for knowledge: You are always eager to learn.
• No non-sense mentality: You can be straightforward respectfully.
• Innovative: You are constantly seeking new and better solutions.
• Not too serious: Your job is important, but you don’t take yourself too seriously.

What’s in it for you?

• QbD Group offers an attractive and competitive salary package, tailored to individual needs, considering legal requirements and local laws.
• Join us to build a sustainable career with job security and meaningful connections.
• As a knowledge-based company, you’ll embark on continuous learning and development.
• Be part of our global success story. We value everyone's contribution and celebrate achievements together.

Our promise to you:

• As an ambitious and pioneering company, we aim to provide the best environment for you to thrive in the life sciences.
• We strive to create a joyful community where you can be yourself and grow together.
• 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. Who knows, you might soon join our QbD family!

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