Consultant Regulatory Affairs Pharma Regulatory Affairs • • Hybrid Remote

TRIUM Clinical Consulting NV; Valladolid; A distancia; EUR 40.000 - 55.000; Jornada completa

Descripción de la vacante

A leading company in the life sciences sector is seeking a Regulatory Affairs Consultant to support clients throughout the regulatory lifecycle. The role involves regulatory writing, project management, and maintaining industry knowledge. Join a global team dedicated to excellence and growth.

Servicios

Competitive salary package

Opportunities for career growth

Inclusive community

Formación

• Relevant initial regulatory affairs experience.
• Basic knowledge of European and UK pharmaceutical regulations.

Responsabilidades

• Provide regulatory writing services for clinical documents.
• Ensure timely delivery of projects with high quality standards.
• Monitor changes in guidance and legislation.

Conocimientos

Attention to detail

Strong communication skills

Organizational skills

Analytical mindset

Educación

University degree in life sciences or chemistry

Descripción del empleo

QbD Group - Regulatory Affairs Consultant Role

QbD Group offers knowledge and tailored (software) solutions in development, clinical, regulatory & compliance, production, and distribution for companies active in Pharma, Biotech, and Medical Devices / IVD sectors.

Our Regulatory Affairs division supports customers throughout the entire regulatory lifecycle of their products, including pharmaceutical products, generics, vaccines, biologicals, biosimilars, medical devices, IVDs, and ATMPs. We have a strong international presence with over 30 colleagues across Belgium, the Netherlands, the UK, Spain, and Austria, serving a global customer portfolio.

Position: Consultant Regulatory Affairs Pharma

We are seeking a dedicated Consultant Regulatory Affairs Pharma to join our team.

Responsibilities:

• Provide regulatory writing services, focusing on clinical documents such as clinical trial applications, scientific briefing packages, orphan drug designations, and paediatric investigation plans, primarily for European and UK procedures.
• Ensure timely delivery of projects with high quality standards.
• Assist senior team members with project tasks.
• Perform QC functions within the team, including translations and data comparisons.
• Maintain and develop regulatory knowledge to support clients effectively.
• Monitor changes in guidance and legislation in relevant areas and inform the team.
• Build a professional network within the industry.
• Maintain personal training records, timesheets, and project archives.

Candidate Profile:

• University degree in life sciences or chemistry.
• Basic knowledge of European and UK pharmaceutical regulations and guidelines.
• Relevant initial regulatory affairs experience.
• Attention to detail and strong communication skills.
• Organizational skills and analytical mindset.
• Enjoy working in an international environment.

Qualities of a True QbD’er:

• Resilient with a positive attitude.
• Hungry for knowledge and continuous learning.
• Straightforward yet respectful.
• Innovative and solution-oriented.
• Balanced approach to professionalism and approachability.

What We Offer:

• Competitive salary package tailored to individual needs and legal regulations.
• Opportunities for career growth and continuous learning.
• Be part of a successful, award-winning global company that values contributions and celebrates achievements.

Our Commitment:

• Provide an environment conducive to growth in the life sciences sector.
• Create a joyful, inclusive community where individuals can be themselves.
• Our motto: JPEG — Joy in Partnership, going the Extra mile to Get things done!

If interested, send your CV and motivation letter. Join our QbD family!