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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: Attractive salary, health benefits, and opportunities for professional growth.
- Why this job: Shape the future of healthcare by ensuring timely product launches and compliance.
- Qualifications: Degree in life sciences and substantial regulatory experience required.
- Other info: Join a collaborative team in a fast-paced environment with career advancement potential.
The predicted salary is between 54000 - 84000 £ per year.
Responsibilities
- Responsible for the provision of full regulatory input and support for assigned products across the submission and assessment phase which includes the preparation, submission and response to questions for new Marketing Authorisation Applications.
- Manages increasingly complex submissions making decisions independently and with minimal referral to line manager.
- Ensure regulatory submissions are made on time and any delays are communicated to all relevant stakeholders in a timely manner so as to minimize 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.
Principal Regulatory Affairs Officer employer: Select Pharma
Contact Detail:
Select Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Regulatory Affairs Officer
✨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 Principal Regulatory Affairs Officer role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU regulations. We recommend creating a cheat sheet of key legislation and guidelines relevant to the role. This will help you stand out as someone who’s not just qualified but also genuinely interested.
✨Tip Number 3
Showcase your experience with complex submissions during interviews. We suggest using the STAR method (Situation, Task, Action, Result) to clearly articulate your past successes and how they relate to the responsibilities of the job.
✨Tip Number 4
Don’t forget to 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 about their job search!
We think you need these skills to ace Principal Regulatory Affairs Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your regulatory experience, especially in CMC and product lifecycle management. We want to see how your background aligns with the responsibilities listed in the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the Principal Regulatory Affairs Officer role. Share specific examples of your past experiences that relate to the job.
Showcase Your Communication Skills: Since you'll be managing submissions and communicating with stakeholders, it's crucial to demonstrate your strong communication skills in your application. Keep your writing clear and concise!
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 don’t miss out on any important updates during the process.
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 regulations, especially around Marketing Authorisation Applications. Be ready to discuss your experience with CMC submissions and how you've handled complex regulatory challenges in the past.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've made independent decisions in previous roles, particularly when it comes to managing submissions. Highlight situations where you had to communicate delays or issues effectively to stakeholders, as this will demonstrate your ability to minimise business impact.
✨Be Ready for Technical Questions
Expect questions that dive deep into your understanding of Module 3 CTD and quality documentation. Practise explaining your thought process and the steps you take to ensure compliance, as this will show your expertise and confidence in the field.
✨Demonstrate Team Collaboration
Even though the role requires independent decision-making, it's crucial to show that you can work well with others. Prepare to discuss how you've collaborated with cross-functional teams to ensure timely approvals and successful product launches.
