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For Companies At a Glance
- 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.
The Role:
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.
Qualifications & Experience:
- 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 City of 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 City of 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 referrals that could give you the edge.
✨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, so show off your expertise and confidence during those interviews!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and match your skills, making your application stand out from the crowd.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you fresh in the interviewer's mind. Plus, it shows your enthusiasm for the role and helps build a positive rapport with the hiring team.
We think you need these skills to ace Regulatory Affairs Senior Manager in City of 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 regulations relevant to the role will show that you're not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Showcase Your Experience
Prepare to share detailed examples of your past experiences with MAA submissions and regulatory strategies. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewers to see your impact.
✨Communicate Clearly
Since excellent communication skills are a must, practice articulating complex regulatory concepts in simple terms. This will demonstrate your ability to provide guidance to cross-functional teams effectively.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s current projects and regulatory challenges. This shows your interest in the role and helps you gauge if the company aligns with your career goals.
