At a Glance
- Tasks: Lead regulatory affairs for clinical development and ensure compliance with global guidelines.
- Company: Dynamic pharmaceutical company focused on innovation and patient impact.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Join a collaborative team and enhance your leadership skills in a fast-paced environment.
- Why this job: Make a real difference in healthcare by navigating complex regulatory landscapes.
- Qualifications: Bachelor's degree in a scientific discipline; 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.
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.
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.
Senior Manager, Regulatory Affairs employer: Job Search Place Limited
As a Senior Manager in Regulatory Affairs at our company, 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, all while being part of a team dedicated to advancing healthcare solutions. Located in a vibrant area, our workplace fosters innovation and encourages meaningful contributions to impactful projects.
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 professionals in regulatory affairs on LinkedIn or at industry events. Building relationships can open doors and give you insider info on job opportunities.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU and international regulatory frameworks. Be ready to discuss how your experience aligns with the role, especially around managing submissions and approvals.
✨Tip Number 3
Showcase your project management skills! Be prepared to share examples of how you've successfully driven complex submission timelines and navigated regulatory challenges in past roles.
✨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 about their job search.
We think you need these skills to ace Senior Manager, Regulatory Affairs
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 role. 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 communication is key in this role, make sure your application showcases your ability to negotiate with regulatory agencies. Use clear and concise language throughout your documents to demonstrate your written communication prowess.
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 don’t miss out on any important updates during the process!
How to prepare for a job interview at Job Search Place Limited
✨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 theory but can apply it practically.
✨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.
✨Demonstrate Strong Communication Skills
Since you'll be interacting with regulatory agencies, practice articulating your thoughts clearly and confidently. Think about how you can convey complex regulatory requirements to team members who may not have the same background.
✨Build Relationships with Competent Authorities
Discuss your experience in building and maintaining relationships with regulatory bodies. If you have any anecdotes about successful negotiations or collaborations, share them! This will show your ability to navigate the regulatory landscape effectively.
