At a Glance
- Tasks: Lead CMC regulatory strategies for innovative mRNA products and ensure compliance with health authority guidelines.
- Company: Join Moderna, a pioneering biotech company transforming medicine with cutting-edge mRNA technology.
- Benefits: Enjoy top-notch healthcare, generous paid time off, and a supportive work environment.
- Other info: Dynamic workplace with a strong focus on collaboration and career growth opportunities.
- Why this job: Make a real impact in the fast-paced world of biotech and help develop transformative medicines.
- Qualifications: MS/PhD in relevant field and extensive experience in regulatory CMC within the pharmaceutical industry.
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 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.
Responsibilities
- 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.
- Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
- Provide interpretation of regulatory guidance documents, regulations and directives – advise 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).
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.
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.
Location & Company Information
Location: Harwell, UK site. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Moderna champions the significant benefits of in-person collaboration and maintains a 70/30 in-office work model.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. Benefits include best-in-class healthcare, family building benefits, generous paid time off, and resources to support well-being. Benefits may vary by country and employment nature.
About Moderna
Moderna was founded in 2010 to build the leading mRNA technology platform and an ecosystem of teams and partners to develop a broad array of drugs across diverse therapeutic areas. Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants. The company is committed to reasonable accommodation for qualified job applicants with disabilities.
EEO & Accommodations
Moderna is an equal opportunity employer. If you require an accommodation during the hiring process, contact leavesandaccommodations@modernatx.com.
Notes
Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. Resumes will only be accepted from recruiters/agencies with a signed agreement in place.
Associate Director, CMC Regulatory Science, International in City of Westminster employer: Moderna Therapeutics
Moderna is an exceptional employer located at the Harwell, UK site, offering a dynamic work environment that fosters collaboration and innovation in the field of mRNA technology. With a strong commitment to employee well-being, the company provides best-in-class healthcare, generous paid time off, and ample opportunities for professional growth within a culture that values boldness, curiosity, and teamwork. Joining Moderna means being part of a transformative journey to develop groundbreaking medicines that make a real impact on patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, CMC Regulatory Science, International in City of Westminster
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its products. We want to see you shine, so practice common interview questions and think about how your experience aligns with their needs. Show them you’re the perfect fit!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way. It shows your enthusiasm and keeps you fresh in their minds. We love seeing candidates who are proactive and engaged.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we’ve got loads of resources to help you along the way. Let’s get you that Associate Director role!
We think you need these skills to ace Associate Director, CMC Regulatory Science, International in City of Westminster
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Associate Director role. Highlight your experience in CMC regulatory science and how it aligns with our mission at StudySmarter. We want to see how you can contribute to our transformative medicines!
Showcase Your Experience:Don’t just list your qualifications; tell us about your achievements in the pharmaceutical or biotech industry. We love seeing specific examples of how you've successfully managed projects or navigated regulatory challenges in your previous roles.
Be Clear and Concise:When writing your application, clarity is key! Use straightforward language and avoid jargon where possible. We appreciate a well-structured application that makes it easy for us to see your skills and experiences.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows us you’re keen on joining the StudySmarter team!
How to prepare for a job interview at Moderna Therapeutics
✨Know Your CMC Inside Out
Make sure you have a solid grasp of CMC regulatory strategies, especially for global submissions like IND/CTA/BLA/MAA. Brush up on the latest EU and ROW regulations, as well as cGMP standards, so you can confidently discuss how your experience aligns with the role.
✨Prepare for Regulatory Discussions
Anticipate questions about how you would handle interactions with health authorities. Think of examples from your past where you successfully navigated regulatory discussions or resolved compliance issues, and be ready to share these during the interview.
✨Showcase Your Project Management Skills
Since this role involves managing multiple projects in a fast-paced environment, prepare to discuss your project management experience. Highlight specific instances where you balanced competing priorities and delivered results under pressure.
✨Communicate Clearly and Effectively
Exceptional written and oral communication is key for this position. Practice articulating complex regulatory concepts in simple terms, and be prepared to demonstrate your ability to create clear, concise documentation during the interview.
