Sr. Director, Global Regulatory Strategy, Oncology

Moderna; Cambridge (MA); On-site; USD 197,000 - 353,000; Full time

Benefits offered by this job

Healthcare and benefits

Well-being programs

Family planning support

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna Therapeutics in Cambridge, MA seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for oncology programs. You will direct submissions, guide interactions with health authorities, and ensure alignment with business goals across US/EU frameworks.

This senior leader will manage a team and shape regulatory pathways to support timely approvals. The role requires 12+ years in pharma regulatory strategy, LON oncology experience, and a proven track record in major NDA/BLA

Qualifications

• 12+ years in the pharmaceutical industry.
• 8+ years in regulatory strategy, including oncology.
• Strong knowledge of US/EU regulations and CTD filings.
• Excellent written and oral communication.
• Experience developing and implementing regulatory strategies.
• Track record securing product approvals and managing complex portfolios.
• Experience with diverse stakeholders at all levels.

Responsibilities

• Sets strategic direction and leads regulatory submissions and supplements.
• Advises teams on regulatory strategy through development processes.
• Maintains relationships with global health agencies.
• Negotiates with health authorities on filings.
• Reviews data and ensures regulatory compliance.
• Implements policies aligned with international regulators.
• Acts as regulatory affairs executive for trials and filings.
• Monitors regulatory publications for impact.
• Supports preparation of Target Label Profile and core data sheets.
• Collaborates with internal teams to manage submissions.
• Leads global regulatory development plans and strategy alignment.
• Ensures strategy aligns with business objectives and authorities’ negotiations.

Skills

Regulatory strategy

Oncology regulatory

Global regulatory strategy

US/EU regulatory knowledge

CTD experience

Executive leadership

Stakeholder management

Communication skills

Project governance

Regulatory meetings

Regulatory strategy development

Team management

Education

BA/BS in scientific/engineering field

Graduate degree or professional certification (preferred)

Tools

CTD format

Job description

The Role

Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as a novel drug modality. The Sr. Director will be a strategic leader within Regulatory Affairs, 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 global regulatory strategies, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology.

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. Identifies potential areas of regulatory concern and responds to new government/regulatory developments.
• 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 and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
• Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
• Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
• Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
• Ensures development and maintenance of the Target Label Profile and the Company Core Data Sheet for their program(s).
• Reviews all external materials for regulatory compliance.
• Collaborates with internal teams and Moderna partners to achieve project goals, including development content and management submissions to Health Agencies.
• 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 relevant health authorities as appropriate
• 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
• Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables

Here’s What You’ll Bring To The Table

• BA/BS degree in a scientific/engineering discipline
• 12+ years of experience in the Pharmaceutical industry
• 8+ years of experience in Regulatory strategy, including oncology
• Strong knowledge of current US and EU regulations, including specifically: e.g. novel regulatory pathways.
• Strong experience with CTD format and content regulatory filings
• Exceptional written and oral communication
• Experience with developing and implementing competitive regulatory strategies
• Demonstrated track record in securing product approvals and maintaining a complex portfolio
• Experience dealing with broad range of stakeholders at all levels internal and external to the company
• Demonstrated competence in employee management and development
• 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
• Preferred: Graduate degree in a scientific discipline or other relevant graduate discipline or professional certification
• Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.

• 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.

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.

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.

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,

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 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 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.