Consultant Regulatory Affairs Pharma Regulatory Affairs • • Hybrid Remote

TRIUM Clinical Consulting NV; Santa Cruz de Tenerife; A distancia; EUR 35.000 - 65.000; Jornada completa

Descripción de la vacante

An innovative company in the life sciences sector is seeking a Consultant in Regulatory Affairs Pharma. This role involves providing regulatory writing services, ensuring project quality, and assisting senior team members. You'll be part of a vibrant, international team, supporting clients with regulatory compliance across Europe and the UK. The company offers a competitive salary and a supportive environment for professional growth, making it an exciting opportunity for those eager to develop their careers in a dynamic field.

Servicios

Attractive Salary Package

Career Development Opportunities

Continuous Learning

Joyful Community Environment

Formación

• University degree in life sciences or chemistry required.
• General knowledge of European/UK pharmaceutical regulations needed.

Responsabilidades

• Provide regulatory writing services for clinical documents.
• Deliver projects on time and ensure high quality.
• Monitor changes in guidance/legislation.

Conocimientos

Regulatory Affairs Knowledge

Attention to Detail

Written Communication

Analytical Skills

Organizational Skills

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, 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.

Responsibilities:

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), mainly for European and UK procedures.
2. You deliver projects on time and ensure high quality.
3. You assist senior team members with their projects.
4. You perform QC functions within the QbD team (e.g., translations of product information, clinical and nonclinical overviews compared to source data).
5. You develop and maintain regulatory skills and knowledge to effectively support clients.
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?

1. You hold a university degree in life sciences or chemistry.
2. You have general knowledge of European/UK pharmaceutical regulations and guidelines.
3. You have relevant regulatory affairs experience.
4. You demonstrate attention to detail.
5. You possess good written and verbal communication skills.
6. You have good organizational skills and an analytical mindset.
7. You enjoy working in an international environment.

Qualities of a true QbD’er:

• Resilient: Your positive attitude helps you overcome challenges.
• Hungry for knowledge: You are eager to learn.
• No non-sense mentality: You are straightforward but respectful.
• Innovative: You seek new and better solutions.
• Not too serious: You take your work seriously but don’t take yourself too seriously.

What’s in it for you?

• Attractive and competitive salary package tailored to individual needs and compliant with legal requirements.
• Opportunities to build a sustainable career with job security and meaningful connections.
• A continuous journey of learning and development as a knowledge-based company.
• Being part of our global success story, celebrating achievements together.

Our promise to you:

• Providing an environment where you can thrive within the life sciences.
• Creating a joyful community where you can be yourself and grow together.
• Our motto: JPEG — Joy in Partnership, going the Extra mile to Get things done!

Interested? Send us your CV and motivation letter. Who knows, you might soon join our QbD family!