Director, Global Regulatory Strategy

The Role:

Moderna, Inc. is seeking a Director of Regulatory Strategy to develop and lead global strategy for mRESVIA, Modernas late stage / marketed RSV messenger RNA (mRNA) vaccine (Adult indication) to be based in one of Modernas East Coast hubs. The Global Regulatory Lead (GRL) role is intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in expanding the Adult indication, the geographical footprint of the vaccine and gaining market approval for lifecycle and licensure maintenance of mRESVIA. The Director will be a strategic leader within Global Regulatory Science, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology. The Director will provide strategic direction and guidance to the teams. They set the vision, goals, and priorities for regulatory affairs within the organization. The GRL will demonstrate ability to collaborate effectively with cross-functional teams, including research and development, compliance, and marketing. They influence decision-making by providing regulatory insights.

Prior regulatory experience with infectious disease & vaccine development and clinical development is strongly preferred.

Here's What Youll Do:

Serve as global regulatory lead accountable for all regulatory aspects of Modernas RSV mRNA vaccine focused on the Adult indication, including development and implementation of the global regulatory strategy and plans for indication expansion, geographical expansion, and licensure maintenance worldwide.

Working in partnership with a cross-functional team, demonstrated track record of successful collaboration with a team of experts, transparent communication kills and lead/coach of a team of Regulatory professionals

Liaises with cross-functional team members to ensure implementation of regulatory strategy.

Ensure the global regulatory strategy for assigned program is aligned with the business objectives and have been negotiated with relevanthealth authorities as appropriate.

Ensures regulatory risk assessment and mitigation plans are developed and aligned across functions.

Sets strategic direction and overall accountable for the preparation, submission, and follow-up of regulatory documents to health authorities for assigned program.

Liaise with health authorities, internal stakeholders, and external partners to ensure business objectives are achieved as defined.

Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly and effectively with health agencies regarding company's filings.

Reviews and approves regulatory documents and dossiers prior to submission to regulatory authorities.

Supports development and maintenance of the Company Core Data Sheet and local prescribing information for assigned program.

Monitor and interpret changes in the regulatory environment, especially related to the mRNA platform with focus on vaccine development, and communicates potential impact to internal teams.

Identify areas in need of improvement and lead the development and implementation of process improvements

Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.

Heres What Youll Bring to the Table:

BA/BS degree in a scientific/engineering discipline. Advanced degree Preferred.

10+ years of experience in the Pharmaceutical industry

6+ years of experience in Regulatory strategy, including specifically: Vaccine Development

Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Infectious Disease vaccine programs.

Strong experience with CTD format and content regulatory filings

Experience with developing and implementing competitive regulatory strategies

Demonstrated track record in securing product approvals and maintaining a complex portfolio

Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance preferably from at least both US and EU

Direct experience of leading regulatory authority meetings in different phases of drug development

Regulatory knowledge across therapeutic areas including infectious diseases and vaccine development is preferable.

Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)

Ability to work independently to manage multiple projects in a fast-paced environment.

Ability to collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each programs critical regulatory milestones.

Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.

Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, the Project Team and senior management, as relevant.

Identify areas in need of improvement and lead the development and implementation of process improvements.

Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. 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. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity 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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation 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 team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

-