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- Tasks: Lead global regulatory strategies and submissions for diverse products.
- Company: Dynamic biotech company focused on innovative therapies.
- 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 en Asuntos Regulatorios 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 en Asuntos Regulatorios 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 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 Especialista en Asuntos Regulatorios 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 regulatory activities, be sure to emphasise any international experience you have. Mention specific health authorities you've interacted with and the outcomes of those engagements.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates during the process!
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 health authorities, practice how you would lead these interactions. Think about how you would prepare meeting requests and briefing packages. It might be helpful to role-play with a friend to get comfortable with articulating your strategies and responses.
✨Show Your Collaborative Spirit
This position requires cross-functional collaboration, so be prepared to share examples of how you've worked with different teams in the past. Highlight your ability to facilitate information flow and align strategies across departments, as this will show you're a team player.
✨Demonstrate Continuous Improvement Mindset
Talk about any initiatives you've led that improved regulatory processes or documentation. Companies love candidates who can drive change, so come armed with specific examples of how you've identified regulatory risks and implemented solutions in your previous roles.