Associate Director, Global Regulatory Science, CMC
About The Position
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. This role demands a dynamic individual capable of managing multiple projects in a fast and results-oriented environment, dedicated to bringing a new generation of transformative medicines to patients.
Requirements
- BS in 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
- 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.
Nice To Haves
- MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable.
Responsibilities
- 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).
Benefits
- Competitive 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 planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investments to help you plan for the future
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
