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 London employer: G&L Scientific
As a leading player in the pharmaceutical industry, we offer our Regulatory Affairs CMC Specialists a dynamic remote working environment that fosters collaboration across global teams. Our commitment to employee growth is reflected in our continuous training opportunities and a culture that values innovation and excellence, making this an ideal place for professionals looking to make a significant impact in regulatory strategy and product development.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs CMC Specialist in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those with CMC expertise. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨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 topics they'll want to hear about.
✨Tip Number 3
Showcase your cross-functional collaboration skills! During interviews, highlight examples of how you've worked with different teams to drive regulatory strategies. This will demonstrate your ability to align with various stakeholders.
✨Tip Number 4
Don't forget to apply through our website! We love seeing candidates who are genuinely interested in joining our team. Plus, it gives you a chance to showcase your enthusiasm for the role right from the start.
We think you need these skills to ace Regulatory Affairs CMC Specialist in 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 key responsibilities mentioned in the job description.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past experiences with regulatory submissions and interactions with health authorities to really stand out.
Showcase Your Knowledge:Demonstrate your understanding of global regulatory requirements and your experience with peptides and proteins. We love seeing candidates who can articulate their knowledge clearly and confidently.
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 shows you’re keen on joining our team!
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.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges. Think about potential scenarios related to submission planning or health authority interactions, and prepare structured responses that highlight your problem-solving skills and strategic thinking.
✨Showcase Your Collaboration Skills
This role involves a lot of cross-functional teamwork, so be prepared to talk about how you've worked with different teams in the past. Share examples that demonstrate your ability to facilitate communication and align strategies across various stakeholders.
✨Highlight Continuous Improvement Initiatives
Discuss any initiatives you've led that improved regulatory processes or documentation. Companies love candidates who can drive efficiency, so be ready to share specific outcomes from your efforts to enhance regulatory strategies or due diligence activities.
