At a Glance
- Tasks: Drive innovative regulatory strategies and collaborate on global submissions for transformative therapies.
- Company: Join Relay Therapeutics, a pioneering company in precision medicine and drug discovery.
- Benefits: Competitive salary, dynamic work environment, and opportunities for professional growth.
- Other info: Be part of a fearless team dedicated to innovation and collaboration in drug discovery.
- Why this job: Make a real impact in patient care while working with cutting-edge technology and a passionate team.
- Qualifications: B.S. or M.S. with 2+ years of regulatory experience; strong communication and problem-solving skills.
The predicted salary is between 80000 - 107000 £ per year.
The Opportunity: We are looking for a motivated and strategic regulatory professional to join our growing regulatory team at Relay Tx. You will contribute to the development and execution of innovative regulatory strategies to support the advancement of our transformative pipeline. You will support the global regulatory lead to drive regulatory planning and execution for our development programs. You will collaborate with cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions.
Your Role: You will work closely with research and development colleagues to support the development and execution of innovative regulatory strategies for programs ranging from first-in-human through late-stage clinical development, including the implementation of non-clinical and clinical regulatory strategy. You will coordinate the preparation and submission of high quality domestic and global regulatory submission documents (e.g. IND, CTA, NDA/MAA), ensuring compliance with applicable regulations and internal standards. You will assist in the preparation and conduct of meetings with health authorities, which includes the development of robust briefing packages and comprehensive meeting preparation to support successful outcomes of meetings. You will monitor for and integrate regulatory intelligence/guidelines into program strategies and contribute to risk identification and mitigation planning within development teams. You will support the efforts to plan and obtain regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations and contribute to the CDx strategy development and submissions. You will provide oversight to the global regulatory activities that are performed by our Clinical Research Organization (CROs) and regulatory vendors.
Your Background: You have earned your B.S and/or M.S. and bring 2+ years of relevant experience. Advanced degree or education in a scientific field is a plus. You are results-oriented and have working knowledge of the drug development process and regulatory submissions (IND, CTA, NDA/MAA, etc.). Experience in precision oncology, rare disease and/or companion diagnostic (CDx) is a plus. You are a proactive problem-solver, capable of identifying solutions to regulatory challenges. You have strong verbal and written communication skills, including the ability to present strategic regulatory topics to internal teams. You are detail-oriented, organized, and able to work both independently and collaboratively in a fast-paced environment. You are intellectually curious and eager to contribute to a growing team focused on innovation and patient impact.
Manager, Regulatory Affairs in Cambridge employer: Relay Therapeutics
Relay Therapeutics is an exceptional employer that fosters a collaborative and innovative work culture, perfect for those passionate about transforming drug discovery. With a focus on employee growth and development, we offer opportunities to engage in meaningful projects that directly impact patient lives, all while working alongside a world-class team in a dynamic environment. Located in a vibrant area, our team enjoys a supportive atmosphere that encourages creativity and strategic thinking, making Relay Tx a rewarding place to advance your career in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Manager, Regulatory Affairs in Cambridge
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Relay Therapeutics. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Relay Therapeutics.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Relay Therapeutics. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Relay Therapeutics is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Manager, Regulatory Affairs in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Relay Therapeutics!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Relay Therapeutics that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Relay Therapeutics!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Relay Therapeutics, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Relay Therapeutics
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Relay Therapeutics that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Relay Therapeutics’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
