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: Collaborative culture with a commitment to equal opportunity and workplace safety.
- Why this job: Make a real impact in the fast-paced world of transformative medicines and regulatory science.
- Qualifications: MS/PhD in relevant fields and extensive experience in Biologics-focused 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 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.
Associate Director, CMC Regulatory Science, International 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
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their CMC regulatory strategies and be ready to discuss how your experience aligns with their goals. Show them you’re not just another candidate!
✨Tip Number 3
Practice your pitch! Be clear about your experience in Biologics focused Regulatory CMC and how you can contribute to their mission. A confident and concise introduction can make a lasting impression.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in being part of the team at Moderna.
We think you need these skills to ace Associate Director, CMC Regulatory Science, International
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in CMC regulatory science. We want to see how your background aligns with the specific requirements of the Associate Director role, so don’t hold back on showcasing your relevant skills!
Showcase Your Experience:When detailing your work history, focus on your 10+ years in the pharmaceutical or biotech industry. We’re particularly interested in your experience with Biologics-focused Regulatory CMC, so make that shine through in your application.
Be Clear and Concise:We appreciate clarity! Use straightforward language and avoid jargon where possible. This will help us quickly understand your qualifications and how you can contribute to our mission of delivering transformative medicines.
Apply Through Our Website:Don’t forget to submit your application through our official website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at Moderna Therapeutics
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC regulatory strategies, especially for global submissions like IND/CTA/BLA/MAA. Be ready to discuss how you've identified regulatory risks in past projects and how you can apply that experience to the role.
✨Showcase Your Communication Skills
Since exceptional written and oral communication is key for this position, prepare examples of how you've effectively communicated complex regulatory information to diverse teams. Think about times when your communication made a significant impact on project outcomes.
✨Demonstrate Your Project Management Prowess
This role involves managing multiple projects simultaneously, so be prepared to share specific examples of how you've successfully juggled various tasks in a fast-paced environment. Highlight your organisational skills and any tools or methods you use to stay on track.
✨Familiarise Yourself with Current Regulations
Stay updated on the latest EU and ROW regulations, as well as cGMP standards. During the interview, mention any recent changes you've adapted to in your work and how you ensure compliance in your projects. This shows you're proactive and knowledgeable in your field.
