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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 36000 - 60000 £ 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 apply anywhere; focus on companies that align with your values and career goals. We suggest checking out our website for tailored job listings that fit your expertise in regulatory affairs.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We believe showing appreciation for the opportunity can set you apart from other candidates.
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 for the Principal Regulatory Officer role. Highlight your relevant experience in regulatory submissions and CMC expertise, as this will show us that you understand what we're looking for.
Showcase Your Skills: Don’t just list your qualifications; demonstrate how your skills align with our needs. Use specific examples from your past experiences that showcase your ability to manage complex projects and communicate effectively with regulatory authorities.
Be Clear and Concise: When writing your application, keep it clear and to the point. We appreciate attention to detail, so make sure your documents are well-structured and free of errors. This reflects your written communication skills, which are crucial for the role.
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 us you're keen on joining our team!
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 instances where you've successfully handled multiple projects under pressure. Highlight your planning and organisation skills, and how you prioritised tasks to meet strict deadlines.
✨Communicate Like a Pro
As a Principal Regulatory Officer, you'll need to interact with various stakeholders. Practice articulating your thoughts clearly and confidently. Prepare for potential negotiation scenarios and think about how you would present your case to regulatory authorities.
✨Attention to Detail is Key
Given the importance of accuracy in regulatory submissions, be prepared to discuss how you ensure high-quality documentation. Bring examples of how you've reviewed and improved processes to maintain compliance and avoid delays in submissions.
