At a Glance
- Tasks: Shape regulatory strategies for innovative pharmaceutical products and ensure compliance.
- Company: Join a collaborative CMC Regulatory team with a global reach.
- Benefits: Competitive salary, professional growth, and the chance to impact patient access.
- Other info: Opportunity to work on diverse projects across EMEA, Japan, and the US.
- Why this job: Make a real difference in drug development and patient care.
- Qualifications: Five years of CMC lifecycle management experience and a relevant degree.
The predicted salary is between 63000 - 77000 £ per year.
Associate Director/Senior Manager, CMC Regulatory
Help shape the regulatory strategy behind innovative pharmaceutical products across their development and post-approval lifecycles.
In this influential role, you’ll provide scientific CMC expertise, work with multidisciplinary teams across regions, and help advance products towards submission, approval and continued regulatory compliance.
Overview
This is an opportunity to join a small, collaborative CMC Regulatory team supporting multiple products across the EMEA region, while working closely with colleagues in Japan and the US.
The role covers approximately 25% development activity and 75% post-approval work, with a primary focus on small-molecule products.
Key Responsibilities
- Establish and implement CMC regulatory strategies for development projects and approved products.
- Lead the preparation and review of regulatory submission dossiers, including CTD Module 3/source documents and Quality Overall Summaries.
- Prepare regulatory communications, briefing documents and responses to Health Authority questions.
- Provide CMC Regulatory input into submissions, clinical development plans, variations and renewal activities.
- Represent CMC expertise at internal and Health Authority meetings.
- Identify regulatory risks and proactively develop practical solutions.
- Assess proposed manufacturing and quality changes and determine the appropriate regulatory measures.
- Collaborate with CMC, manufacturing, Quality Assurance, clinical, regulatory and commercial stakeholders across regions.
- Support lifecycle management, post-approval changes and delivery of Health Authority commitments.
- Must-Have
- At least five years’ hands-on CMC lifecycle management experience within the EMEA region.
- Experience supporting both development and post-approval activities for small-molecule products.
- Experience preparing regulatory submissions and engaging with regulatory agencies on CMC or Quality matters.
- Strong knowledge of CMC Regulatory Affairs, Quality Assurance, applicable regulations and Health Authority requirements.
- Experience managing multiple projects and working effectively across multidisciplinary teams.
- Bachelor’s degree in Chemistry, Biological Science, Pharmacy or another scientific or technical discipline.
- Nice-to-Have
- Experience with biologics.
- Experience preparing IMPDs or CTAs.
- Laboratory experience.
- Advanced degree such as an MSc or Ph D.
Bring your CMC Regulatory expertise to a role where your work can directly support product development, approval and ongoing patient access–
Associate Director/Senior Manager, CMC Regulatory in London employer: Planet Pharma Group
Planet Pharma Group is an exceptional employer that fosters a dynamic and inclusive work culture, where innovation in healthcare technology thrives. Employees benefit from flexible hybrid working arrangements, comprehensive professional development opportunities, and a commitment to enhancing patient care, making it a rewarding place to grow your career while making a meaningful impact in the industry.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director/Senior Manager, CMC Regulatory in London
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Planet Pharma Group. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Planet Pharma Group.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Planet Pharma Group. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Planet Pharma Group is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Associate Director/Senior Manager, CMC Regulatory in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Planet Pharma Group!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Planet Pharma Group that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Planet Pharma Group!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Planet Pharma Group, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Planet Pharma Group
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Planet Pharma Group that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Planet Pharma Group’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
