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- Tasks: Lead regulatory submissions and ensure compliance for innovative pharmaceutical products.
- Company: Dynamic pharmaceutical company focused on impactful healthcare solutions.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Why this job: Join a team that shapes the future of healthcare through regulatory excellence.
- Qualifications: Degree in life sciences and substantial regulatory experience required.
- Other info: Fast-paced environment with opportunities to manage complex projects independently.
The predicted salary is between 48000 - 72000 £ per year.
Responsibilities:
- Provision of full regulatory input and support for assigned products across the submission and assessment phase, including preparation, submission, and response to questions for new Marketing Authorisation Applications.
- Manage increasingly complex submissions, making decisions independently and with minimal referral to line manager.
- Ensure regulatory submissions are made on time and communicate any delays to all relevant stakeholders in a timely manner to minimise impact to the business.
- Provide regulatory input on pharmaceutical development and CMC, and review quality documentation to ensure regulatory compliance with UK and EU legislation.
- Provide regulatory input on artworks and ensure approval in time for product launch and compliance with legislation and guidelines.
Qualifications and Required Experience:
- Degree in a suitable scientific discipline (biological/chemistry/life sciences).
- Substantial regulatory experience across the full product lifecycle.
- Strong CMC regulatory experience, including preparation and review of Module 3 CTD.
- Solid understanding of pharmaceutical manufacturing processes, analytical methods, and regulatory expectations for CMC compliance.
- Broad experience of managing relevant regulatory submissions, with demonstrated ability to work independently and manage complex projects.
- In-depth knowledge of UK and European regulatory affairs legislation and guidance.
- Planning and organisation skills; ability to handle multiple tasks/projects and manage priorities accordingly.
- Able to work under pressure and to strict deadlines.
- A confident credible communicator with good negotiation skills.
- Able to build relationships at all levels of the business.
- Excellent written communication skills with attention to detail.
- Able to independently identify and initiate tasks/projects.
Principal Regulatory Affairs Officer in Sunbury-on-Thames employer: Select Pharma
Contact Detail:
Select Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Regulatory Affairs Officer in Sunbury-on-Thames
✨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 when it comes to landing that Principal Regulatory Affairs Officer role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU regulatory affairs legislation. We recommend creating a cheat sheet of key points to discuss, especially around CMC compliance and submission processes. This will show you’re not just knowledgeable but also passionate about the field!
✨Tip Number 3
Don’t forget to showcase your project management skills! When discussing your experience, highlight specific examples where you managed complex submissions or worked under pressure. We want to see how you can handle multiple tasks while keeping everything compliant and on track.
✨Tip Number 4
Finally, apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who are proactive and take the initiative to connect with us directly.
We think you need these skills to ace Principal Regulatory Affairs Officer in Sunbury-on-Thames
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Principal Regulatory Affairs Officer role. Highlight your regulatory experience and any specific projects that showcase your ability to manage complex submissions. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention your understanding of UK and EU regulations and how your skills can contribute to our team. Keep it engaging and personal – we love a bit of personality!
Showcase Your Communication Skills: Since excellent written communication is key for this position, make sure your application is clear and concise. Pay attention to detail in your writing, as this reflects your ability to handle regulatory documentation. We appreciate clarity and professionalism!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re proactive and keen to join our team at StudySmarter!
How to prepare for a job interview at Select Pharma
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of UK and EU regulatory affairs legislation. Be ready to discuss specific examples from your experience that demonstrate your understanding of the full product lifecycle and CMC compliance.
✨Showcase Your Project Management Skills
Prepare to talk about how you've managed complex submissions in the past. Highlight your ability to work independently and handle multiple projects simultaneously, as this role requires strong planning and organisation skills.
✨Communicate Clearly and Confidently
Since this position involves liaising with various stakeholders, practice articulating your thoughts clearly. Use examples that showcase your negotiation skills and ability to build relationships at all levels of the business.
✨Attention to Detail is Key
Be prepared to discuss how you ensure compliance with quality documentation and regulatory expectations. Bring examples of how your attention to detail has positively impacted your previous projects, especially regarding submission deadlines.
