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For Companies At a Glance
- Tasks: Lead regulatory strategies and collaborate with global teams to improve lives through biotechnology.
- Company: Globally recognised pioneer in the Biotechnology industry.
- Benefits: 12-month contract with opportunities for professional growth and impactful work.
- Why this job: Join a mission-driven team making a real difference in healthcare.
- Qualifications: Experience in regulatory affairs and knowledge of drug development processes.
- Other info: Dynamic role with exposure to international regulatory environments.
The predicted salary is between 36000 - 60000 £ per year.
Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Regulatory Affairs Manager. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions. This is your chance to join them on their global mission to better the lives of those affected by disease and illness.
Responsibilities include:
- Advising the GRT on regional considerations in developing strategy
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May manage one or more regional leads or support roles
- May participate as a member of: Global Regulatory Team (GRT), Global Development Team (GDT), Clinical Study Team (CST), Label Working Group (LWG), Regional Teams (e.g. IMT, IBT, NAMT)
- Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment
- Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant senior management
- Under general supervision, participate in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy, including contingency regulatory planning/risk assessment
Knowledge and Skills required:
- Regulatory principles
- Working with policies, procedures and SOPs
- Knowledge of relevant legislation and regulations relating to medicinal products
- Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals
- Knowledge of drug development
- Cultural awareness and sensitivity to achieve results across both regional country and international borders
If this role is of interest to you, please apply now!
Regulatory Affairs Manager employer: Quanta part of QCS Staffing
Contact Detail:
Quanta part of QCS Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory principles and relevant legislation. We recommend practising common interview questions with a friend or even in front of the mirror to boost your confidence.
✨Tip Number 3
Showcase your cultural awareness and sensitivity during interviews. We know that working across borders is key in this role, so share examples of how you've successfully navigated diverse environments in the past.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who want to make a difference in the life sciences sector.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience with regulatory principles and any relevant legislation you've worked with. We want to see how your skills align with the job description!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the life sciences sector and how you can contribute to our mission. Don’t forget to mention your experience with regional stakeholders and regulatory agencies.
Showcase Your Knowledge: In your application, demonstrate your understanding of drug development and regulatory procedures. We’re looking for someone who knows their stuff, so don’t hold back on sharing your insights and experiences in this area!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen to join our team at StudySmarter!
How to prepare for a job interview at Quanta part of QCS Staffing
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory principles and legislation related to medicinal products. Familiarise yourself with the specific regulations in the region you're applying for, as well as the processes for marketing authorisations and clinical trial applications.
✨Show Your Team Spirit
This role involves collaboration with various teams like the Global Regulatory Team and Clinical Study Team. Be ready to discuss your experience working in cross-functional teams and how you've successfully navigated different stakeholder interests in past projects.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and ability to handle regulatory challenges. Think of examples where you've had to manage risks or develop contingency plans, and be prepared to explain your thought process.
✨Cultural Awareness is Key
Given the global nature of the role, demonstrate your understanding of cultural sensitivity and how it impacts regulatory affairs. Share experiences where you've successfully worked across different cultures or regions to achieve results.
