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- Tasks: Lead regulatory support for pharmaceutical products, ensuring timely submissions and compliance.
- Company: Join a dynamic pharmaceutical company focused on innovation and compliance.
- Benefits: Competitive salary, career growth opportunities, and a collaborative work environment.
- 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 independently.
The predicted salary is between 36000 - 60000 £ 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 due diligence and report writing; ability to write up a report with the information found (deficiencies, errors etc in the dossier or territory specific updates needed prior to submission).
- 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 London employer: Select Pharma Recruitment
Contact Detail:
Select Pharma Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Regulatory Affairs Officer in London
✨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 regulatory 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 underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation. We believe this small gesture can leave a lasting impression and keep you top of mind for the hiring team.
✨Tip Number 4
Apply through our website for the best chance at landing the job! We make it easy for you to showcase your skills and experience directly to recruiters. Plus, it shows you’re genuinely interested in joining our team!
We think you need these skills to ace Principal Regulatory Affairs Officer in London
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 align with the responsibilities mentioned in the job description. We want to see how your skills fit right into our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you the perfect fit for this position. We love seeing genuine enthusiasm, so let your personality come through!
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just listing duties. Did you manage a complex submission successfully? Share that story! We appreciate candidates who can demonstrate their impact in previous roles.
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 Recruitment
✨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 past experience where you've successfully managed complex submissions or navigated regulatory challenges.
✨Showcase Your Project Management Skills
Prepare to talk about how you've handled multiple projects simultaneously. Think of a time when you had to prioritise tasks under pressure and how you communicated delays to stakeholders. This will demonstrate your planning and organisation skills.
✨Communicate Clearly and Confidently
Practice articulating your thoughts clearly, especially when discussing technical topics like CMC compliance or report writing. Good communication is key, so consider doing mock interviews with a friend to refine your delivery.
✨Build Rapport with the Interviewers
Remember, interviews are a two-way street! Engage with your interviewers by asking insightful questions about their team and projects. This shows you're genuinely interested and can help you build relationships right from the start.
