The Role
Moderna’s London office is focused on commercial operations, ensuring delivery of our mRNA products to the UK market. As Manager, Regional Regulatory Strategist, you will play a critical role in advancing the global regulatory path for Moderna’s mRNA programs in the European Union and international markets.
What You’ll Do
* 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.
Additional Responsibilities
* 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.
Qualifications
* Degree in Life Science or related discipline; advanced degree preferred (PharmD, MSc, PhD).
* 5+ years of experience in the pharmaceutical industry, 3+ years 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 meet 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.
Pay & Benefits
* Best‑in‑class 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 building benefits, including fertility, adoption, and surrogacy support.
* Generous paid time off, including vacation, bank holidays, 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.
Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com.
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