Consultant Regulatory Affairs Pharma Regulatory Affairs • • Hybrid Remote

TRIUM Clinical Consulting NV; Burgos; A distancia; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A premier consulting company in the life sciences sector is seeking a Consultant Regulatory Affairs Pharma. You will be responsible for regulatory writing and project delivery while assisting senior team members in an international environment. This role offers a competitive salary, continuous learning, and the opportunity to contribute to the company's global success in a supportive and innovative culture.

Servicios

Attractive salary package

Job security

Continuous learning and development

Global success celebrations

Formación

• You have general knowledge of European / UK pharmaceutical regulations.
• You have a first relevant regulatory affairs experience.
• You enjoy working in an international environment.

Responsabilidades

• Provide regulatory writing services with emphasis on clinical documents.
• Assist senior team members with projects and provide QC functions.
• Monitor changes in guidance and maintain regulatory skills.

Conocimientos

Attention to detail

Communication skills

Organizational skills

Analytical mindset

Educación

University degree in life science 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?

• You provide a range of regulatory writing services with supervision of senior team members with an emphasis on clinical documents (clinical trial applications, scientific briefing packages, orphan drug designations, paediatric investigation plans) with a focus on European and UK procedures.
• You deliver projects on time and to a high quality.
• You assist senior team members with their projects.
• 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).
• You develop and maintain regulatory skills and knowledge necessary to ensure effective support to clients.
• You monitor change in guidance / legislation in designated areas and inform the team.
• You build a network of industry colleagues and professional associations.
• You complete basic job-related responsibilities e.g. maintenance of personal training record, timesheets, project archiving.

Who are we looking for?

• You have a university degree in life science or chemistry.
• You have general knowledge of European / UK pharmaceutical regulations and guidelines.
• You have a first relevant regulatory affairs experience.
• You have attention to detail.
• You have 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 any challenge.
• Hungry for knowledge : You are always open to learning.
• No non-sense mentality : you can be straightforward in a respectful way.
• Innovative : You are constantly looking for new and better solutions.
• Not too serious : your job is serious, but you don’t take yourself too seriously.

What’s in it for you?

• QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
• As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
• Be part of our global success story. As an award-winning company, we value everyone’s contribution and celebrate achievements together.

Our promise to you :

• As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
• Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
• In short … We stand for? JPEG : J oy in P artnership, going for the E xtra mile to G et things done!

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!

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