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For Companies At a Glance
- Tasks: Lead global regulatory submissions and shape strategies for product development.
- Company: Dynamic company focused on innovative healthcare solutions.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement.
- Why this job: Make a real impact in global health by shaping regulatory strategies.
- Qualifications: 10-15 years in Regulatory Affairs with strong CMC expertise.
The predicted salary is between 70000 - 90000 £ 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 Slough 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 Slough
✨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 this role.
✨Tip Number 3
Showcase your cross-functional collaboration skills! Be prepared to share examples of how you've worked with different teams to drive regulatory strategies and improve processes. This will highlight your ability to fit into their matrix team.
✨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 take that extra step to engage with us directly.
We think you need these skills to ace Regulatory Affairs CMC Specialist in Slough
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Affairs CMC Specialist role. Highlight your experience with peptides and proteins, and showcase your understanding of global regulatory requirements. We want to see how your skills align with what we're looking for!
Showcase Your Experience: When detailing your work history, focus on your achievements in regulatory submissions and interactions with health authorities. Use specific examples that demonstrate your expertise in CMC and your ability to drive successful product development. This is your chance to shine!
Be Clear and Concise: Keep your application straightforward and to the point. Avoid jargon unless it's relevant to the role. We appreciate clarity, so make it easy for us to see why you're a great fit for the position without wading through unnecessary fluff.
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it makes the whole process smoother for everyone involved!
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 implemented 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 with Cross-Functional Teams
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 and submissions.
✨Demonstrate Continuous Improvement Mindset
Discuss any initiatives you've led or been part of that aimed at improving regulatory processes. This could include streamlining documentation or enhancing submission quality. Showing that you're proactive about continuous improvement will resonate well with the interviewers.