Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead global regulatory strategies and submissions for innovative products.
- Company: Dynamic company focused on advancing healthcare through regulatory excellence.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and innovation.
- Why this job: Shape the future of healthcare by engaging with global health authorities.
- Qualifications: 10-15 years in Regulatory Affairs with strong CMC expertise.
The predicted salary is between 60000 - 80000 £ per year.
We are seeking an experienced Regulatory Affairs professional with strong CMC expertise to support global regulatory activities across a diverse portfolio. This role is ideal for someone with advanced knowledge of regulatory requirements and experience across multiple modalities, particularly peptides and proteins.
You will play a key role in shaping regulatory strategy, leading submissions, and engaging with global health authorities to ensure successful product development and lifecycle management.
Key Responsibilities- Regulatory Strategy & Submissions
- Lead submission planning by applying regulatory intelligence and developing effective global regulatory strategies
- Prepare, compile, and maintain high-quality regulatory dossiers
- Manage and execute submissions to health authorities worldwide, including: MAA, NDA, BLA, CTA/IND, Device Files, CE marking, NBOp, Site Master Files, Renewals, post-approval changes, and commitments
- Respond to health authority questions and ensure timely follow-up
- Health Authority Interactions
- Plan and lead regulatory interactions with global health authorities
- Prepare meeting requests, briefing packages, and coordinate rehearsals
- Document and communicate outcomes from formal meetings
- Support affiliates in preparing for regulatory interactions
- Cross-functional Collaboration
- Act as a key member of the RA matrix team
- Represent Regulatory Affairs to ensure alignment of strategy and planning
- Facilitate effective information flow across cross-functional teams
- Collaborate with affiliates and internal stakeholders globally
- RA Process Lead
- Drive continuous improvement in regulatory processes, documentation, and strategy development
- RA Due Diligence Expert
- Lead regulatory due diligence activities, including: Assessment of CMC data packages and development plans, Identification of critical regulatory risks, Evaluation of product positioning and competitive landscape
- CMC Product Lead
- Own the overall RA CMC/device regulatory strategy (including DDC products)
- Align with global and affiliate teams to ensure timely execution
- Communicate business-critical decisions, risks, and resource constraints
Essential skills:
- Around 10-15 years of experience in Regulatory Affairs
- Advanced understanding of regulatory affairs, with strong CMC expertise
- Experience with multiple modalities (peptides and proteins highly desirable)
- In-depth knowledge of global regulatory requirements (USA, EU, Japan, China)
- Experience across all stages of drug development, including lifecycle management (LCM)
- Proven track record of managing global regulatory submissions and health authority interactions
- Experience authoring Module 3 CTD documentation
Regulatory Affairs CMC Specialist in City of London employer: G&L Scientific
Contact Detail:
G&L Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs CMC Specialist in City of London
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those with CMC expertise. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory requirements. Be ready to discuss your experience with submissions and health authority interactions, as these are key areas for the role.
✨Tip Number 3
Showcase your collaborative spirit! Highlight examples of how you've worked cross-functionally in previous roles. Employers love candidates who can facilitate effective information flow and align strategies across teams.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for talented individuals like you to join our team!
We think you need these skills to ace Regulatory Affairs CMC Specialist in City of London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in Regulatory Affairs, especially your CMC expertise. We want to see how your background aligns with the job description, so don’t be shy about showcasing your relevant skills and experiences!
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. We love seeing passion and enthusiasm, so let us know what excites you about working with us at StudySmarter and how you can contribute to our team.
Highlight Your Global Experience: Since this role involves engaging with global health authorities, make sure to emphasise any international experience you have. Whether it’s working with different regulatory bodies or managing submissions across various regions, we want to hear about it!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we do at StudySmarter!
How to prepare for a job interview at G&L Scientific
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory requirements, especially around CMC for peptides and proteins. Be ready to discuss specific examples from your past experience where you've successfully navigated complex submissions or interactions with health authorities.
✨Showcase Your Strategic Thinking
Prepare to talk about how you've developed and executed regulatory strategies in previous roles. Think of a couple of key projects where your strategic input made a difference, and be ready to explain your thought process and the outcomes.
✨Engage in Cross-Functional Collaboration
Highlight your experience working with cross-functional teams. Be prepared to share examples of how you've facilitated communication and collaboration between different departments to ensure alignment on regulatory strategies.
✨Be Ready for Health Authority Scenarios
Anticipate questions about how you would handle interactions with global health authorities. Consider discussing a challenging situation you've faced in the past and how you managed it, focusing on your approach to preparing for meetings and following up on queries.