At a Glance
- Tasks: Lead CMC regulatory strategies for innovative mRNA products and ensure compliance with health authority guidelines.
- Company: Join a pioneering biotech company dedicated to transforming medicine.
- Benefits: Comprehensive healthcare, wellness resources, generous paid time off, and family support benefits.
- Other info: Dynamic work environment with opportunities for professional growth and development.
- Why this job: Make a real impact in the fast-paced world of transformative medicines.
- Qualifications: Advanced degree in relevant field and extensive experience in regulatory CMC.
The predicted salary is between 80000 - 100000 £ per year.
The Associate Director, CMC Regulatory Science-International will be based at the Harwell, UK site and as part of a team be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of mRNA products. This position will contribute to and support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Development of regulatory strategy for the products in our portfolio will be a key success component.
Here’s What You’ll Do:
- Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
- Provide guidance for regulatory CMC aspects of product development projects
- Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
- Drive Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
- Support the development of regulatory processes and procedures to support CMC components of regulatory submissions
- Support the creation and maintenance of CMC submission templates
- Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls
- Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
- Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)
Here’s What You’ll Need (Basic Qualifications):
- MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
- 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
- 8+ years of experience in Biologics focused Regulatory CMC
- As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check
Here’s What You’ll Bring to the Table (Preferred Qualifications):
- Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)
- Strong knowledge of current EU and ROW regulations
- Strong knowledge of cGMP
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
- Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being with access to fitness, mindfulness, and mental health support
- Family building benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation
Associate Director, CMC Regulatory Science, International in London employer: Moderna Therapeutics
Moderna Therapeutics is an exceptional employer located in Oxford, offering a dynamic work culture that fosters innovation and collaboration. With a strong emphasis on employee well-being and career development, the company provides a comprehensive benefits package and ample opportunities for professional growth, making it an ideal place for those passionate about advancing the future of medicine.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, CMC Regulatory Science, International in London
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We think you need these skills to ace Associate Director, CMC Regulatory Science, International 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 Moderna Therapeutics!
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 Moderna Therapeutics 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 Moderna Therapeutics!
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 Moderna Therapeutics, 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 Moderna Therapeutics
✨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 Moderna Therapeutics 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 Moderna Therapeutics’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.
