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- Tasks: Lead global regulatory strategies and submissions for diverse products.
- 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: 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 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
- 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
ESPECIALISTA DE CUMPLIMIENTO 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 ESPECIALISTA DE CUMPLIMIENTO 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 cross-functional collaboration skills! Be prepared to share examples of how you've worked with different teams to drive regulatory strategies and improve processes.
✨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 connect with us directly.
We think you need these skills to ace ESPECIALISTA DE CUMPLIMIENTO 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 key responsibilities mentioned in the job description.
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. Share specific examples of your past experiences that relate to regulatory strategy and submissions.
Showcase Your Global Experience: Since this role involves global health authority interactions, be sure to emphasise any international experience you have. We love candidates who can navigate different regulatory landscapes!
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. We can’t wait to see what you bring to the table!
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 and the specific modalities mentioned in the job description. Be ready to discuss your experience with peptides and proteins, as well as any global regulatory submissions you've managed.
✨Prepare for Health Authority Interactions
Since this role involves engaging with global health authorities, practice how you would lead these interactions. Think about how you would prepare meeting requests and briefing packages, and be ready to share examples of past experiences where you successfully navigated similar situations.
✨Show Your Cross-Functional Collaboration Skills
This position requires working closely with various teams. Be prepared to discuss how you've facilitated effective information flow in previous roles and how you’ve collaborated with different stakeholders to achieve regulatory goals.
✨Demonstrate Continuous Improvement Mindset
Highlight any experiences where you've driven improvements in regulatory processes or documentation. Share specific examples that showcase your ability to assess risks and enhance strategies, as this will resonate well with what they’re looking for.