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- Tasks: Lead regulatory strategy and manage submissions for innovative therapies in Europe.
- Company: Dynamic pharmaceutical company focused on improving patients' lives.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real impact by ensuring compliance and guiding innovative products to market.
- Qualifications: Experience in EMA regulatory affairs and strong communication skills required.
- Other info: Join a collaborative team dedicated to excellence and patient care.
The predicted salary is between 43200 - 72000 £ per year.
We are supporting a pharmaceutical company committed to delivering innovative therapies that improve patients’ lives in recruiting a Senior Regulatory Manager. Their global teams collaborate to bring cutting-edge solutions from concept to market while maintaining the highest standards of quality and compliance.
We are seeking an experienced Senior Regulatory Manager with strong expertise in EMA regulatory affairs to join their dynamic team. This role offers the opportunity to lead regulatory strategy, manage submissions, and act as a key regulatory advisor for our product portfolio across the European region.
Key Responsibilities:- Develop and execute regulatory strategies for products under development and marketed products in Europe, ensuring alignment with EMA requirements.
- Lead and manage EMA submissions, including MAA, variations, line extensions, and renewals.
- Act as primary liaison with EMA, competent authorities, and other regulatory bodies.
- Provide regulatory guidance to cross-functional teams (R&D, clinical, quality, commercial) throughout the product lifecycle.
- Evaluate and interpret new regulations, guidance, and industry trends to ensure ongoing compliance.
- Contribute to internal audits, inspections, and regulatory intelligence initiatives.
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline.
- Strong regulatory affairs experience with a focus on EMA submissions.
- Proven experience in preparing and submitting MAA, CTD dossiers, variations, and renewals.
- Strong understanding of EU pharmaceutical regulations and guidelines.
- Excellent written and verbal communication skills.
- Demonstrated ability to lead projects and influence cross-functional teams.
Regulatory Affairs Senior Manager in London employer: Park Street People
Contact Detail:
Park Street People Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Senior Manager in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on EMA regulations and recent changes in the industry. We want you to be the go-to person for regulatory knowledge during your interview!
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've influenced cross-functional teams in past roles. We love hearing about real-life examples that demonstrate your impact.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate candidates like you to join our team.
We think you need these skills to ace Regulatory Affairs Senior Manager in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Manager role. Highlight your experience with EMA submissions and any relevant projects you've led. We want to see how your background aligns with what we're looking for!
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 you can contribute to our mission of delivering innovative therapies. Keep it concise but impactful!
Showcase Your Communication Skills: Since excellent communication is key in this role, make sure your application reflects that. Use clear and professional language, and don’t forget to proofread for any typos or errors. We love attention to detail!
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 a few clicks and you’re done!
How to prepare for a job interview at Park Street People
✨Know Your Regulations
Make sure you brush up on the latest EMA regulations and guidelines. Being able to discuss specific examples of how you've navigated these in past roles will show your expertise and confidence.
✨Showcase Your Strategy Skills
Prepare to talk about how you've developed and executed regulatory strategies in previous positions. Use concrete examples to illustrate your thought process and decision-making skills.
✨Communicate Clearly
Since this role involves liaising with various teams, practice articulating complex regulatory concepts in simple terms. Clear communication is key, so consider doing mock interviews to refine your delivery.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or changes in legislation. Think through potential scenarios beforehand and prepare your responses to demonstrate your problem-solving abilities.
