Global Oncology Regulatory Strategy Director

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

Benefits offered by this job

Competitive healthcare

Well-being programs

Generous paid time off and sabbatical

Location-specific perks

Job summary

Moderna Therapeutics in Cambridge seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for oncology programs, guiding filings and interactions with health authorities.

This newly created role demands strategic vision, deep regulatory knowledge, and a collaborative approach across R&D, clinical development, and business teams. You will shape global regulatory strategies, address risks and opportunities, manage submission content (CTD), and mentor teams while ensuring

Qualifications

• 12+ years of experience in the pharmaceutical industry.
• 8+ years in regulatory strategy, including oncology.
• Strong knowledge of US/EU regulations, including novel regulatory pathways.
• Experience with CTD format and regulatory filings.
• Exceptional written and oral communication skills.
• Experience leading regulatory authority meetings and strategies.

Responsibilities

• Sets strategic direction and leads regulatory submissions and supplements.
• Advises teams on regulatory strategy through development processes.
• Identifies regulatory concerns and tracks new developments.
• Maintains relationships with global health agencies.
• Negotiates with health authorities on filings and data requests.
• Reviews data for regulatory compliance and approves documentation.
• Develops policies aligned with international regulations.
• Leads regulatory development plans across programs.

Skills

Regulatory strategy

Regulatory leadership

CTD knowledge

Regulatory submissions

US/EU regulations

Oncology experience

Stakeholder management

Regulatory meetings

Written & oral communication

Education

BA/BS in science/engineering

Graduate degree preferred

Job description

Moderna Therapeutics in Cambridge seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for oncology programs, guiding filings and interactions with health authorities.

This newly created role demands strategic vision, deep regulatory knowledge, and a collaborative approach across R&D, clinical development, and business teams. You will shape global regulatory strategies, address risks and opportunities, manage submission content (CTD), and mentor teams while ensuring