Associate Director, Global Regulatory Science, CMC
Moderna
Summary
Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the development of global products. The successful candidate will lead and support all regulatory activities, ensuring the delivery of high-quality CMC sections of regulatory documentation.
Job description
Here's What You'll Do
- Developing and implementing effective CMC regulatory strategies for international submissions (e.g., IND/CTA/BLA/MAA) and identifying regulatory risks.
- Providing guidance on regulatory CMC aspects of product development projects.
- Reviewing documents for submission readiness, ensuring conformity to health authority guidelines.
- Leading Regulatory CMC discussions and interactions with health authorities to facilitate the review and approval of submissions.
- Developing regulatory processes and procedures to support the CMC components of regulatory submissions.
- Supporting the creation and maintenance of CMC submission templates.
- Providing CMC regulatory guidance to manufacturing and quality teams; evaluating CMC change controls.
- Offering interpretations of regulatory guidance documents, regulations, and directives, advising on their applicability and impact on internal programs.
- Leading oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases).
The key Moderna Mindsets you'll need to succeed in the role
- Pursue options in parallel: This role requires a strategic thinker who can explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies.
- Act with urgency: Given the fast-paced and result-oriented environment, acting swiftly and decisively is crucial to meet deadlines and deliver transformative medicines to patients.
Here's What You'll Need (Basic Qualifications)
- BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
- MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable.
- 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus.
- 8+ years of experience in Biologics focused Regulatory CMC.
- 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.
Our Working Model
Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.
Requirements
- BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
- 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
- 8+ years of experience in Biologics focused Regulatory CMC
- 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
Benefits
- Competitive healthcare
- Fitness support
- Mindfulness support
- Mental health support
- Family planning benefits
- Fertility support
- Adoption support
- Surrogacy support
- Paid time off
- Volunteer days
- Sabbatical
- Global recharge days
- Year-end shutdown
- Savings and investments
Company overview
Moderna, Inc. is a pioneering American biotechnology and pharmaceutical company headquartered in Cambridge, Massachusetts, that has revolutionized the field of medicine through its groundbreaking messenger RNA (mRNA) technology. Founded in 2010, the company has established itself as a global leader in RNA therapeutics, primarily focusing on mRNA vaccines and treatments. Moderna's innovative platform uses mRNA to provide cellular instructions for producing proteins that trigger immune responses, creating a new category of medicines with significant potential to improve patient outcomes across various therapeutic areas. The company gained worldwide recognition during the COVID-19 pandemic for developing one of the earliest and most effective mRNA vaccines, which demonstrated the transformative potential of its technology platform. Beyond infectious diseases, Moderna is advancing a diverse pipeline of 44 treatment and vaccine candidates across infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune conditions. With approximately 5,800 employees and a strong commitment to scientific innovation, Moderna continues to expand its manufacturing capabilities and research initiatives to deliver the greatest possible impact through mRNA medicines.