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- Tasks: Join our team to provide regulatory writing services and support senior members.
- Company: QbD Group specializes in tailored solutions for Pharma, Biotech, and Medical Devices.
- Benefits: Enjoy a competitive salary, job security, and continuous learning opportunities.
- Why this job: Be part of an award-winning company that values contributions and fosters a joyful community.
- Qualifications: A degree in life science or chemistry with knowledge of European/UK regulations is required.
- Other info: We celebrate achievements together and encourage innovation and personal growth.
The predicted salary is between 28800 - 43200 £ per year.
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 informs 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 serious.
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!
Consultant Regulatory Affairs Pharma employer: QbD Group
Contact Detail:
QbD Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Consultant Regulatory Affairs Pharma
✨Tip Number 1
Familiarize yourself with the latest European and UK pharmaceutical regulations. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends and challenges in the field.
✨Tip Number 3
Showcase your attention to detail by preparing for discussions about specific regulatory documents. Being able to discuss clinical trial applications or orphan drug designations confidently can set you apart.
✨Tip Number 4
Emphasize your ability to work in an international environment. Share any experiences you've had working with diverse teams or on global projects, as this aligns well with our company culture.
We think you need these skills to ace Consultant Regulatory Affairs Pharma
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and expectations of a Consultant Regulatory Affairs Pharma. Familiarize yourself with the types of documents you'll be working on, such as clinical trial applications and scientific briefing packages.
Tailor Your CV: Customize your CV to highlight relevant experience in regulatory affairs, particularly any work related to European and UK pharmaceutical regulations. Emphasize your attention to detail and organizational skills, as these are crucial for the role.
Craft a Strong Motivation Letter: In your motivation letter, express your passion for regulatory affairs and your eagerness to contribute to the QbD Group. Mention specific experiences that demonstrate your knowledge of regulations and your ability to deliver high-quality work.
Showcase Your Soft Skills: Highlight your communication skills and your ability to work in an international environment. Provide examples of how you've successfully collaborated with colleagues or clients from diverse backgrounds, as this aligns with the company's values.
How to prepare for a job interview at QbD Group
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of European and UK pharmaceutical regulations. Familiarize yourself with key documents like clinical trial applications and orphan drug designations, as these will likely come up during your interview.
✨Showcase Your Attention to Detail
Prepare examples that demonstrate your attention to detail, especially in regulatory writing or QC functions. Highlight any experiences where your meticulousness led to successful project outcomes.
✨Emphasize Your Communication Skills
Since good written and verbal communication is crucial for this role, be ready to discuss how you've effectively communicated complex information in past roles. Consider preparing a brief presentation on a relevant topic to showcase your skills.
✨Demonstrate Your Willingness to Learn
Express your eagerness to stay updated on changes in guidance and legislation. Share any recent learning experiences or professional development activities that illustrate your commitment to continuous improvement in the field.
