At a Glance
- Tasks: Lead regulatory affairs for clinical development and ensure compliance with global guidelines.
- Company: Join a dynamic pharmaceutical company making a difference in healthcare.
- Benefits: Competitive salary, career growth, and opportunities to work with international teams.
- Other info: Collaborative environment with strong focus on professional development and cross-functional teamwork.
- Why this job: Make an impact by navigating complex regulatory landscapes and driving successful product approvals.
- Qualifications: Bachelor's degree in relevant fields and 5+ years of regulatory experience required.
The predicted salary is between 60000 - 80000 € per year.
The Senior Manager, Regulatory Affairs, EU & ROW will manage assigned regulatory affairs activities through preclinical and clinical development.
Key Responsibilities
- Ensures timely planning, coordination, submission and approval of clinical trial applications, PIPs, scientific advice briefing books, marketing applications, etc.
- Interact with regulatory agencies and develop and maintain strong relationships with competent authorities both remotely and face to face.
- Responsible for submitting high quality regulatory documents required to obtain successful outcomes.
- Manage activities required to meet regulatory requirements, global guidelines and other required procedures within assigned projects.
- Own and manage document development and submission such as IMPDs, scientific advice briefing books etc.
- Act as EU/ROW regulatory representative on clinical study teams and translate regulatory requirements for project team members.
- File and track of regulatory activities for assigned projects, and maintain internal processes to ensure compliance.
- Provide support to cross functional project team members on Regulatory matters impacting the project.
Minimum Qualifications
- Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines.
- Bachelor’s degree in Regulatory Affairs, Life Sciences, or a related discipline required, Master’s degree preferred.
- 5+ years of experience in regulatory affairs within pharmaceuticals, biotechnology, or medical devices.
- Minimum 3 years of managerial or team‑lead experience.
- Demonstrated success managing regulatory submissions and product approvals.
Preferred Skills & Experience
- Deep knowledge of U.S., EU, and international regulatory frameworks (FDA, EMA, ISO, MDD/MDR, GxP).
- Strong project management and organizational skills with ability to drive complex submission timelines.
- Excellent written and verbal communication; strong ability to negotiate with regulatory agencies.
- Analytical problem‑solving skills with proven ability to assess regulatory risks and impact.
- Cross‑functional leadership and influence across diverse teams.
Essential Physical Requirements
- Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
- Ability to operate a computer keyboard and telephone.
- Ability to sit for extended periods of time – up to four (4) hours at a time.
- Ability to articulate clearly and conduct verbal presentations with large and small audiences.
- Ability to travel via automobile and/or airplane.
- Ability to lift, tug, pull up to fifteen (15) pounds.
To be considered for this position, you must apply and meet the requirements of this opportunity.
NOTE: This job description is not intended to be all‑inclusive. Employee may perform other related duties as negotiated to meet the on‑going needs of the organization.
Senior Manager, Regulatory Affairs in London employer: Silence Therapeutics plc
As a Senior Manager in Regulatory Affairs at our London office, you will thrive in a dynamic and supportive work environment that prioritises employee growth and development. We offer competitive benefits, a collaborative culture, and the opportunity to engage with leading regulatory agencies, ensuring your contributions have a meaningful impact on global health outcomes. Join us to be part of a forward-thinking team dedicated to innovation and excellence in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Regulatory Affairs in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who have experience with EU and ROW regulations. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory frameworks like FDA and EMA. We recommend creating a list of common interview questions and practising your responses, focusing on your project management and negotiation skills.
✨Tip Number 3
Showcase your experience! When you get the chance to discuss your past roles, highlight specific examples of successful regulatory submissions and approvals. This will demonstrate your expertise and make you stand out.
✨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 are proactive and engaged in their job search.
We think you need these skills to ace Senior Manager, Regulatory Affairs in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that match the Senior Manager, Regulatory Affairs role. Highlight your regulatory submissions and approvals experience, as well as any managerial roles you've held.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this position. Mention your deep knowledge of regulatory frameworks and how your project management skills can drive success in our team.
Showcase Your Communication Skills:Since excellent written and verbal communication is key for this role, make sure your application is clear and concise. Use professional language but keep it friendly – we want to see your personality shine through!
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 to do!
How to prepare for a job interview at Silence Therapeutics plc
✨Know Your Regulatory Frameworks
Make sure you brush up on your knowledge of U.S., EU, and international regulatory frameworks. Be ready to discuss how these regulations impact the projects you'll be managing. This shows that you’re not just familiar with the rules but can also apply them effectively.
✨Showcase Your Project Management Skills
Prepare examples that highlight your project management experience, especially in driving complex submission timelines. Use specific instances where you successfully managed a regulatory submission or overcame challenges to meet deadlines. This will demonstrate your organisational skills and ability to lead.
✨Communicate Clearly and Confidently
Practice articulating your thoughts clearly, especially when discussing technical documents like IMPDs or scientific advice briefing books. Strong communication is key in this role, so consider doing mock interviews to refine your verbal presentation skills.
✨Build Rapport with Regulatory Agencies
Think about how you can demonstrate your ability to build relationships with regulatory agencies. Share past experiences where you successfully negotiated or collaborated with these authorities. This will show that you understand the importance of maintaining strong connections in regulatory affairs.
