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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 48000 - 72000 £ 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 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 regulations. We recommend creating a cheat sheet of key legislation and guidelines relevant to the role. This will help you impress interviewers with your expertise and confidence!
✨Tip Number 3
Showcase your experience with complex submissions during interviews. We suggest using the STAR method (Situation, Task, Action, Result) to structure your answers. This way, you can clearly demonstrate your ability to manage submissions independently.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of resources to help you prepare for your application and interviews. Plus, applying directly shows your enthusiasm for the role and the company!
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 and any relevant qualifications. We want to see how your background aligns with the responsibilities of the Principal Regulatory Affairs Officer role, so don’t hold back on showcasing your skills!
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. We love seeing enthusiasm and a clear understanding of the job, so let your personality come through while keeping it professional.
Be Clear and Concise: When filling out your application, clarity is key. We appreciate straightforward answers that get to the point. Avoid jargon unless it’s relevant to the role, and make sure your writing is easy to follow.
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’s super easy – just follow the prompts and you’ll be set!
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 navigated complex regulatory landscapes in the past.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've independently managed submissions and resolved issues without needing to escalate them. This role requires a lot of decision-making, so demonstrating your ability to think on your feet will impress the interviewers.
✨Communicate Clearly and Effectively
Since you'll need to keep stakeholders informed about submission timelines and any potential delays, practice articulating your thoughts clearly. Use specific examples from your past roles where effective communication made a difference.
✨Be Ready for Technical Questions
Expect some in-depth questions about Module 3 CTD and quality documentation. Brush up on your technical knowledge and be prepared to discuss how you've ensured compliance in previous roles. This will show that you're not just familiar with the theory but have practical experience too.
