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For Companies At a Glance
- Tasks: Lead regulatory strategy and manage submissions for innovative therapies in Europe.
- Company: Join a forward-thinking pharmaceutical company dedicated to improving patient lives.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real impact by ensuring compliance and guiding cutting-edge therapies to market.
- Qualifications: Experience in EMA regulatory affairs and strong communication skills required.
- Other info: Dynamic team environment with a commitment to equal opportunities.
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.
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.
Regulatory Affairs Senior Manager 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
✨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 recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your knowledge.
✨Tip Number 3
Showcase your leadership skills! Be ready to share examples of how you've successfully led projects or influenced teams in your previous roles. This will highlight your ability to manage cross-functional teams effectively.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace Regulatory Affairs Senior Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in EMA regulatory affairs. We want to see how your background aligns with the key responsibilities mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for the Senior Regulatory Manager role. Share specific examples of your past achievements in regulatory strategy and submissions to grab our attention.
Showcase Your Communication Skills: Since excellent communication is key, ensure your application reflects your ability to convey complex regulatory information clearly. We love candidates who can communicate effectively with cross-functional teams!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity.
How to prepare for a job interview at Park Street People
✨Know Your EMA Inside Out
Make sure you brush up on your knowledge of EMA regulations and guidelines. Familiarise yourself with recent changes and how they impact submissions. This will not only show your expertise but also demonstrate your commitment to staying updated in the field.
✨Prepare for Scenario Questions
Expect questions that ask you to describe how you've handled specific regulatory challenges in the past. Prepare examples that highlight your problem-solving skills and ability to lead cross-functional teams through complex regulatory processes.
✨Showcase Your Communication Skills
As a Senior Regulatory Manager, you'll need to liaise with various stakeholders. Be ready to discuss how you've effectively communicated regulatory strategies and compliance requirements to different teams. Practice articulating your thoughts clearly and confidently.
✨Demonstrate Strategic Thinking
Think about how you can contribute to the company's regulatory strategy. Be prepared to discuss your approach to developing and executing regulatory strategies for both new and existing products. Highlight any innovative ideas you have that could benefit their portfolio.
