Consultant Regulatory Affairs Pharma Regulatory Affairs • • Hybrid Remote

TRIUM Clinical Consulting NV; Salamanca; A distancia; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

Join a dynamic team as a Consultant in Regulatory Affairs Pharma, where your expertise will help navigate the regulatory landscape for pharmaceutical products. This role offers a chance to engage with a diverse range of projects, focusing on clinical documents and ensuring compliance with European and UK regulations. You will thrive in an international environment, supported by a collaborative team dedicated to continuous learning and development. With a competitive salary package and a commitment to fostering a joyful community, this is an opportunity to build a sustainable career while making a meaningful impact in the life sciences industry.

Servicios

Attractive Salary Package

Job Security

Continuous Learning Opportunities

Supportive Work Environment

Formación

• Experience in regulatory affairs is preferred.
• Knowledge of European and UK pharmaceutical regulations is essential.

Responsabilidades

• Provide regulatory writing services for clinical documents.
• Assist senior team members and perform quality control functions.
• Monitor changes in guidance and legislation.

Conocimientos

Regulatory Affairs Knowledge

Attention to Detail

Written Communication Skills

Organizational Skills

Analytical Mindset

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, focusing on clinical documents (clinical trial applications, scientific briefing packages, orphan drug designations, paediatric investigation plans) with supervision of senior team members, primarily for European and UK procedures.
2. You deliver projects on time and maintain high quality standards.
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 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 possess general knowledge of European and UK pharmaceutical regulations and guidelines.
• You have some relevant regulatory affairs experience.
• You demonstrate attention to detail.
• You have good written and verbal communication skills.
• You exhibit good organizational skills and an analytical mindset.
• 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 can be straightforward respectfully.
• Innovative: You constantly seek better solutions.
• Balanced: You take your work seriously but don't take yourself too seriously.

What’s in it for you?

• QbD Group offers an attractive, competitive salary package tailored to individual needs, considering legal and local laws.
• Build a sustainable career with job security and meaningful connections.
• Engage in continuous learning and development as part of a knowledge-based company.
• Be part of our global success story, celebrating achievements together.

Our promise to you:

• We aim to provide the best environment for growth within the life sciences.
• We foster a joyful community where you can be yourself and grow together as individuals.
• Our motto: JPEG — Joy in Partnership, going the Extra mile to Get things done!

Interested? Send us your CV and motivation letter — we might welcome you soon into our QbD family!

J-18808-Ljbffr