Consultant Regulatory Affairs Pharma Regulatory Affairs • • Hybrid Remote

TRIUM Clinical Consulting NV; Málaga; A distancia; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

An innovative consulting firm is seeking a motivated Consultant in Regulatory Affairs Pharma to join their dynamic team. In this role, you'll provide essential regulatory writing services, ensuring compliance with European and UK procedures. You'll collaborate with senior team members, perform quality checks, and develop your regulatory knowledge while working in a supportive, international environment. This position offers a chance to thrive in a knowledge-based company that values continuous learning and celebrates individual contributions. If you're passionate about life sciences and eager to make a meaningful impact, this opportunity is perfect for you.

Servicios

Competitive Salary

Job Security

Continuous Learning Environment

Global Organization

Meaningful Connections

Formación

• University degree in life sciences or chemistry.
• Basic knowledge of European and UK pharmaceutical regulations.

Responsabilidades

• Providing regulatory writing services for clinical documents.
• Ensuring project delivery on time and maintaining high quality standards.
• Monitoring changes in guidance and legislation relevant to the role.

Conocimientos

Regulatory Writing

Attention to Detail

Organizational Skills

Communication Skills

Knowledge of Pharmaceutical Regulations

Educación

University Degree in Life Sciences

University Degree in 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, including pharmaceutical products, generics, vaccines, biologicals, biosimilars, medical devices, IVDs, and ATMPs. Our team has a strong international presence with over 30 colleagues across Belgium, the Netherlands, the UK, Spain, and Austria. Our global customer portfolio spans Asia, the US, Europe, and Africa.

Position: Consultant Regulatory Affairs Pharma

We are seeking a motivated individual to join our team as a Consultant Regulatory Affairs Pharma.

Responsibilities include:

1. Providing regulatory writing services, focusing on clinical documents such as clinical trial applications, scientific briefing packages, orphan drug designations, and paediatric investigation plans, primarily within European and UK procedures.
2. Ensuring project delivery on time and maintaining high quality standards.
3. Assisting senior team members with various projects.
4. Performing QC functions within the QbD team, including translation checks and data comparisons.
5. Developing and maintaining regulatory knowledge to support clients effectively.
6. Monitoring changes in guidance and legislation relevant to the role and informing the team accordingly.
7. Building a network of industry colleagues and professional associations.
8. Completing basic administrative responsibilities such as maintaining training records, timesheets, and project archiving.

Candidate Profile:

• University degree in life sciences or chemistry.
• Basic knowledge of European and UK pharmaceutical regulations and guidelines.
• Relevant initial experience in regulatory affairs.
• Attention to detail and strong organizational skills.
• Excellent written and verbal communication skills.
• Enjoys working in an international environment.

Qualities of a True QbD’er:

• Resilient with a positive attitude.
• Hungry for knowledge and continuous learning.
• Straightforward and respectful communication.
• Innovative mindset seeking better solutions.
• Balanced approach to work and fun, not too serious.

What We Offer:

• Competitive salary tailored to individual needs, complying with legal and local regulations.
• Opportunities for building a sustainable career with job security and meaningful connections.
• A continuous learning environment within a knowledge-based company.
• Being part of a global, award-winning organization that values contributions and celebrates successes.

Our Promise:

• Providing an environment where you can thrive within the life sciences sector.
• Fostering a joyful community where individuality is celebrated.
• Living our values: JPEG — Joy in Partnership, going the extra mile to get things done!

Interested?

Send us your CV and motivation letter. Join the QbD family and be part of our success story!