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- Tasks: Lead regulatory submissions and ensure compliance for new product launches.
- Company: Dynamic pharmaceutical company focused on innovation and quality.
- Benefits: Competitive salary, flexible working hours, and opportunities for professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while developing your regulatory expertise.
- Qualifications: Degree in life sciences and substantial regulatory experience required.
- Other info: Fast-paced environment with opportunities to manage complex projects and build key relationships.
The predicted salary is between 48000 - 72000 £ per year.
Role:
Ensure timely and effective regulatory submissions are made to support the objectives of the New Product Delivery (NPD) team. Contribute and Support team and company objectives in line with regulatory and other relevant requirements as well as internal and external standards. Provide CMC regulatory expertise across product development, due diligence and reviewing documentation to ensure accuracy and high quality.
Key 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
- Takes responsibility for proactively managing complex issues with regulatory authorities, third parties and internal colleagues to ensure swift approvals of regulatory applications. Interacts directly with regulatory authorities on defined matters, liaise with, and make presentations to regulatory authorities on defined matters including negotiating regarding marketing authorisations.
- Provide regulatory input on pharmaceutical development and CMC and review quality documentation to ensure regulatory compliance with UK and EU legislation
- Perform Due Diligence on dossiers under development and ready for in-licensing.
Qualifications, Experience & Knowledge Required:
- 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 Officer employer: Invenia Group
Contact Detail:
Invenia Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Regulatory Officer
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory 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 Officer role.
✨Tip Number 2
Prepare for interviews by brushing up on your CMC regulatory knowledge. We recommend practising common interview questions and scenarios related to regulatory submissions. Show them you’re the expert they need!
✨Tip Number 3
Don’t just wait for job openings to pop up! Keep an eye on our website and apply proactively. Sometimes, the best opportunities come from expressing your interest before a position is even advertised.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds. We believe this small gesture can make a big difference!
We think you need these skills to ace Principal Regulatory Officer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your relevant experience in regulatory submissions. We want to see how your skills align with the role of Principal Regulatory Officer, so don’t hold back on showcasing your CMC expertise!
Showcase Your Achievements: When detailing your past roles, focus on specific achievements that demonstrate your ability to manage complex regulatory submissions. Use metrics where possible to illustrate your impact – numbers speak volumes!
Be Clear and Concise: We appreciate clarity! Ensure your written application is well-structured and free from jargon. Highlight your key skills and experiences succinctly, as this will make it easier for us to see why you’re a great fit.
Apply Through Our Website: Don’t forget to submit your application through our website! This helps us keep track of all applications and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Invenia Group
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of UK and EU regulatory affairs legislation. Be prepared to discuss specific examples from your experience that demonstrate your understanding of CMC compliance and the product lifecycle.
✨Showcase Your Project Management Skills
Since the role involves managing complex submissions, be ready to share how you've successfully handled multiple projects in the past. Highlight your planning and organisation skills, and give examples of how you prioritised tasks under pressure.
✨Communicate Clearly and Confidently
As a Principal Regulatory Officer, you'll need to interact with regulatory authorities and internal stakeholders. Practice articulating your thoughts clearly and confidently, and prepare for potential negotiation scenarios that may come up during the interview.
✨Prepare for Technical Questions
Expect technical questions related to pharmaceutical manufacturing processes and analytical methods. Review relevant documentation and be ready to discuss how you ensure accuracy and high quality in your submissions.
