Sr. Director, Regulatory Strategy, Infectious Disease

Initial Therapeutics, Inc.; Cambridge (MA); On-site; USD 197,000 - 353,000; Full time

Job summary

Moderna, Inc. seeks a Senior Director of Regulatory Strategy to lead regulatory programs from its Cambridge, MA headquarters or East Coast hubs.

This strategic leader will craft global regulatory plans for mRNA infectious disease vaccines, coordinating with Regulatory Affairs, RA CMC, and cross-functional teams to address challenges and opportunities. The role requires 12+ years in pharma with vaccine regulatory experience, a track record of approvals, and strong communication with health

Qualifications

• BA/BS degree in a scientific/engineering discipline; advanced degree preferred.
• 12+ years of experience in the Pharmaceutical industry.
• 8+ years in Regulatory strategy, including vaccine development.
• Expert knowledge of FDA, EU, ICH guidelines for infectious disease vaccines.
• Strong experience with CTD format and regulatory filings.
• Proven track record in securing product approvals and managing complex portfolios.
• Experience leading regulatory authority meetings in different phases of drug development.
• Ability to lead cross-functional teams and manage multiple projects.
• Excellent verbal and written communication skills.

Responsibilities

• Sets strategic direction and leads regulatory submissions content and amendments.
• Advises teams on regulatory strategy through clinical and nonclinical development.
• Identifies regulatory risks and responds to new developments.
• Maintains relationships with global health agencies and negotiates with authorities.
• Reviews data partnerships and ensures accuracy of clinical data for filings.
• Collaborates with internal and external partners to meet milestones.

Skills

Regulatory strategy leadership

FDA/EU/ICH guidelines

CTD filings

Vaccine development

Cross-functional collaboration

Regulatory authority meetings

Global regulatory strategy

Mentoring/regulatory team

Education

BA/BS in science/engineering

Advanced degree preferred

Job description

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 Moderna’s 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.

Here’s What You’ll 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 company's 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

Here’s What You’ll 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 program’s 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. That’s why our benefits and well-being resources are designed to support you—at 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 $196,700.00 - $353,400.00. 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 individual’s 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.

Equal Opportunities

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 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

We’re 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 [e-mail].

Export Control NoticeThis 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 applicant’s 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.