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- Tasks: Lead regulatory strategies for innovative cell and gene therapy products from development to approval.
- Company: Join a cutting-edge biopharmaceutical company focused on transformative therapies.
- Benefits: Enjoy competitive salary, professional development opportunities, and a collaborative work environment.
- Why this job: Be at the forefront of groundbreaking therapies and make a real impact in healthcare.
- Qualifications: Bachelor's degree in life sciences required; 4-8 years of regulatory experience preferred.
- Other info: Opportunity to mentor junior staff and work with global regulatory agencies.
The predicted salary is between 60000 - 84000 £ per year.
This is a fully remote opportunity to join an rapidly growing and reputable Biotech company in the Cell and Gene Therapy space.
They are seeking a Senior Regulatory Affairs Manager, experienced in biologic clinical trial applications across UK/EU and, US experience is a bonus.
Responsibilities:
- Planning, coordination, preparation, review and submission of regulatory applications and submissions.
- You will be responsible for assigned clinical studies including trial documentation, review and planning submissions.
- Coordinate, review and respond to queries from regulatory agencies.
- Support maintenance and approval of drug applications to the regulatory agencies throughout the whole lifecycle of the product.
- Ensure correct procedures are followed relating to advanced medicinal therapy products.
- Keep up to date with Cell & Gene therapy regulatory intelligence.
Requirements:
- 6-8 years of experience within the biotech and/or a pharmaceutical sector within regulatory affairs
- Proven experience in completing and submitting clinical trial applications in Europe, preferably Europe and United States.
- Experience the planning, coordination and execution of Scientific Advice or other regulatory agency meetings.
- Having experience in other key areas of the product lifecycle, such as, marketing authorisation applications (MAA\’s)
- Scientific and regulatory writing skills.
- Strong communication skills.
- Ability to work remotely and autonomously.
Senior Manager Regulatory Affairs employer: Discover International
Contact Detail:
Discover International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Regulatory Affairs
✨Tip Number 1
Familiarize yourself with the latest regulatory guidelines specific to cell and gene therapy. Understanding the nuances of frameworks like FDA's RMAT and EMA's ATMP will give you a significant edge in discussions and interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with cell and gene therapies. Engaging in conversations can provide insights into industry trends and may lead to valuable connections.
✨Tip Number 3
Prepare to discuss your previous experiences with regulatory submissions and approvals. Be ready to share specific examples of how you've navigated challenges and collaborated with cross-functional teams to achieve successful outcomes.
✨Tip Number 4
Showcase your leadership skills by highlighting any mentoring or team management experiences. Emphasizing your ability to foster collaboration and knowledge sharing will resonate well with our team-oriented culture.
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 relevant experience in regulatory affairs, particularly in cell and gene therapy. Emphasize your achievements in leading regulatory submissions and interactions with health authorities.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your passion for regulatory affairs and your specific experience with cell and gene therapies. Mention how your skills align with the key responsibilities of the role.
Highlight Leadership Experience: Since the position involves team leadership, be sure to include examples of how you've successfully led teams or mentored junior staff in your previous roles.
Showcase Strategic Thinking: Provide examples in your application that demonstrate your strategic thinking and decision-making abilities, especially in developing regulatory strategies for complex products.
How to prepare for a job interview at Discover International
✨Showcase Your Regulatory Expertise
Be prepared to discuss your experience with regulatory submissions, particularly in the context of cell and gene therapy. Highlight specific examples where you successfully led submissions or interacted with agencies like the FDA or EMA.
✨Demonstrate Strategic Thinking
Illustrate your ability to develop and execute comprehensive regulatory strategies. Discuss how you align these strategies with corporate objectives and how you've navigated challenges in past projects.
✨Highlight Cross-Functional Collaboration
Emphasize your experience working with diverse teams, such as clinical, CMC, and quality departments. Provide examples of how you facilitated communication and coordinated efforts to achieve regulatory goals.
✨Prepare for Risk Management Discussions
Be ready to talk about how you identify and evaluate regulatory risks. Share your approach to risk mitigation and any specific instances where you successfully addressed regulatory challenges in the cell and gene therapy space.
