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 regulatory agencies.
- Other info: Collaborative environment with strong focus on professional development.
- Why this job: Shape the future of medicine by navigating complex regulatory landscapes.
- Qualifications: Bachelor's degree in relevant fields and 5+ years in regulatory affairs 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 employer: Silence Therapeutics plc
As a leading player in the pharmaceutical and biotechnology sector, our company offers an exceptional work environment for the Senior Manager, Regulatory Affairs role. Located in vibrant London, we foster a collaborative culture that prioritises employee growth through continuous learning opportunities and mentorship. Our commitment to innovation and excellence is matched by our dedication to maintaining strong relationships with regulatory agencies, ensuring that our team members are at the forefront of industry developments while enjoying a supportive and dynamic workplace.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Regulatory Affairs
✨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. Be ready to discuss your past experiences managing submissions and approvals. We want to see how you can bring that expertise to our team!
✨Tip Number 3
Showcase your project management skills! During interviews, highlight specific examples where you successfully drove complex submission timelines. This will demonstrate your ability to handle the demands of the Senior Manager role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Senior Manager, Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in regulatory affairs, especially in managing submissions and approvals. 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 is your chance to shine! Use it to explain why you're the perfect fit for the Senior Manager role. Share specific examples of your past successes in regulatory affairs and how they relate to our needs at StudySmarter.
Showcase Your Communication Skills:Since excellent written communication is crucial for this role, ensure your application is clear, concise, and free of errors. We appreciate well-structured documents that reflect your ability to communicate effectively with regulatory agencies.
Apply Through Our Website:Don't forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the position. Plus, it makes the whole process smoother for everyone involved.
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
Highlight your project management experience during the interview. Prepare examples of how you've successfully driven complex submission timelines in the past. This will demonstrate your ability to manage multiple tasks and lead teams effectively.
✨Prepare for Regulatory Agency Interactions
Think about your past experiences interacting with regulatory agencies. Be ready to share specific instances where you negotiated or communicated effectively with these bodies. This will illustrate your strong communication skills and ability to build relationships.
✨Demonstrate Cross-Functional Leadership
Be prepared to discuss how you've influenced diverse teams in previous roles. Share examples of how you’ve supported cross-functional project team members on regulatory matters. This will show that you can lead and collaborate effectively across different areas.
