Manager, Regional Regulatory Strategist

Support the development and execution of regulatory strategy for assigned programs in the EU and international markets in collaboration with Global Regulatory Leads, Regional Regulatory Strategists, and Country Regulatory Leads.,Prepare and contribute to regulatory submissions including Scientific Advice meeting requests, briefing documents, clinical trial applications, orphan drug designations, pediatric plans, expedited pathway applications, DSURs, and marketing authorization applications (MAA).,Coordinate aspects of regulatory submissions relevant to the assigned program(s), ensuring alignment with global strategy and timelines.,Support regulatory interactions with the EMA and other international health authorities.,Engage with cross-functional regulatory teams to ensure consistency, compliance, and strategy execution.,Identify, assess, and manage regulatory risks associated with assigned program(s).,Track, follow up, and archive correspondence, regulatory commitments, and queries from EMA and international agencies.,Work independently and collaboratively in matrixed project teams to achieve program goals.,Apply critical thinking to anticipate potential regulatory hurdles and proactively address challenges specific to mRNA as a novel modality.,Contribute to continuous improvement and innovation within regulatory processes.

Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD).,5+ years of experience in the pharmaceutical industry.,3+ years of experience in Regulatory strategy.,Strong experience with CTD format and content of regulatory filings.,Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and/or relevant International markets.,Ability to work independently to manage multiple projects in a fast-paced environment.,Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones.,Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.,A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Bachelor's Degree (advanced degree preferred)

Must embrace a 70/30 in-office work model (70% in-office, 30% remote). Moderna is a smoke-free, alcohol-free, and drug-free work environment.