At a Glance
- Tasks: Lead regulatory affairs for innovative RNAi therapies and manage submissions for clinical trials.
- Company: Silence Therapeutics, a pioneer in RNAi technology with a mission to improve patient outcomes.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on innovation and collaboration.
- Why this job: Join a cutting-edge company making a real difference in healthcare and patient lives.
- Qualifications: Bachelor's degree in a scientific discipline and 5+ years in regulatory affairs required.
The predicted salary is between 60000 - 80000 € per year.
About the Company
Our 20-plus years of RNAi experience together with our validated mRNAi GOLD™ platform make us a partner of choice for pharmaceutical companies looking to access the benefits of the siRNA and add this revolutionary modality to their discovery pipeline. As pioneers in the design and development of siRNAs (short interfering RNAs), Silence Therapeutics is advancing a new generation of medicines to potentially address the needs of patients who have limited or inadequate treatment options. Our mission is to use our technology to create a new generation of therapeutics that can improve patient outcomes and, in the process, build shareholder value. We are developing a deep pipeline of innovative siRNAs based on our mRNAi GOLD™ platform for diseases with a genetic basis. The depth and versatility of our liver-targeting technology gives us the opportunity to address a wide range of conditions in virtually any therapeutic area. Our wholly owned pipeline is currently focused in three therapeutic areas of high unmet need: hematology, cardiovascular, and rare diseases.
About the Role
The Senior Manager, Regulatory Affairs, EU & ROW will manage assigned regulatory affairs activities through preclinical and clinical development.
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.
Qualifications
- Minimum 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.
Required Skills
- 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.
Preferred Skills
Essential Physical Requirements
- Ability to view video display terminal images.
- 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.
Silence Therapeutics is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
Senior Manager Regulatory Affairs in City of London employer: Silence Therapeutics plc
At Silence Therapeutics, we pride ourselves on being an exceptional employer, offering a collaborative and innovative work culture that empowers our employees to make a meaningful impact in the field of biotechnology. With over 20 years of experience and a commitment to advancing therapeutics, we provide ample opportunities for professional growth and development, alongside competitive benefits and a supportive environment that values diversity and inclusion. Join us in our mission to revolutionise patient care while enjoying the unique advantages of working in a pioneering company located at the forefront of scientific discovery.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Regulatory Affairs in City of London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Silence Therapeutics. A friendly chat can open doors and give you insights that might just help you land that Senior Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory frameworks. Be ready to discuss how your experience aligns with the responsibilities listed in the job description. We want to see your passion for regulatory affairs shine through!
✨Tip Number 3
Showcase your project management skills! Think of examples where you've successfully managed complex submissions or led teams. This is key for the Senior Manager position, so make sure to highlight these experiences during your conversations.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining our team at Silence Therapeutics.
We think you need these skills to ace Senior Manager Regulatory Affairs in City of London
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Senior Manager Regulatory Affairs role. Highlight your relevant experience in regulatory submissions and your understanding of EU and international frameworks. We want to see how your background aligns with our mission!
Showcase Your Achievements:Don’t just list your responsibilities; share specific achievements that demonstrate your success in managing regulatory submissions. Use metrics where possible to show how you’ve positively impacted previous projects. This helps us see the value you can bring to our team.
Be Clear and Concise:When writing your application, clarity is key! Use straightforward language and avoid jargon unless it’s relevant to the role. We appreciate a well-structured application that makes it easy for us to understand your qualifications and experiences.
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 us you’re genuinely interested in joining our team at Silence Therapeutics!
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 prepared 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
Since this role requires strong project management abilities, come ready with examples of how you've successfully managed complex submission timelines in the past. Highlight any tools or methodologies you used to keep everything on track.
✨Prepare for Cross-Functional Collaboration
This position involves working with diverse teams, so think about times when you’ve led cross-functional projects. Be ready to share how you navigated different perspectives and ensured everyone was aligned on regulatory requirements.
✨Practice Your Communication Skills
Excellent communication is key in this role, especially when negotiating with regulatory agencies. Prepare to demonstrate your verbal and written communication skills during the interview. You might even want to practice explaining complex regulatory concepts in simple terms.
