Sr. Director, Regulatory Strategy, Infectious Disease

The Role:

Moderna Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters or one of Modernas East Coast hubs. This role is intended for a forward looking creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA infectious disease vaccines as unprecedented new drug modality globally. The Sr. Director will be a strategic leader within Global Regulatory Science responsible for developing and executing regulatory plans for assigned programs 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. Prior regulatory experience with infectious disease & vaccine development preferred.

Heres What Youll Do:

• Sets strategic direction and leads the development of content format and accountability for regulatory submissions and related supplements and amendments.

• Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes.

• Conducts risks and gaps assessment and Identifies potential areas of regulatory concern and responds to new government/regulatory developments.

• Monitors regulatory developments related to mRNA platform with focus on vaccine development and advises project teams regarding the development and implementation of regulatory strategy through the clinical development processes.

• Establishes and maintains excellent relationships with global health agencies.

• Responds to requests for additional data organizes and manages participation in meetings. Negotiates directly and effectively with health agencies regarding companys filings.

• Reviews and approves technical data in partnership with RA CMC and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.

• Provides input on trials and filing activities and ensures that report systems are maintained and compliant.

• Collaborates with internal teams globally and Moderna partners to achieve project goals including development content and management submissions to Health Agencies.

• Demonstrates strong cultural awareness and sensitivity value diverse perspectives and experiences and foster an inclusive environment where all individuals feel respected and heard.

• Serves as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s) including development and implementation of the global regulatory development plan for the project.

• Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevanthealth authorities as appropriate

• 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

• Manages a team of Regulatory strategists that are responsible for the portfolio deliverables for COVID facing programs

Heres What Youll Bring to the Table:

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

• 12 years of experience in the Pharmaceutical industry

• 8 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 effectively 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.

• May be responsible for line management and development of direct reports.

• 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.

Our Working Model

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

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our benefits and well-being resources are designed to support youat work at home and everywhere in between.

• 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

The salary range for this role is $196700.00 - $353400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individuals position within the salary range will be based on several factors including but not limited to specific competencies relevant education qualifications certifications experience skills performance and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus other incentive compensation or equity award subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure 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 people are 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.

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

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can 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 .

Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NH1

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