Chief Regulatory & Development Strategy Officer

Moderna, Inc. - Chief Regulatory & Development Strategy Officer
Company: Moderna, Inc.
Position: Chief Regulatory & Development Strategy Officer
Department: Executive Leadership / Regulatory Affairs
Location: Cambridge, Massachusetts, USA
Work Model: Hybrid, with business travel as required
Reports To: Chief Executive Officer

Position Overview
Moderna is a biotechnology company focused on developing medicines and vaccines using messenger RNA technology. The proposed Chief Regulatory & Development Strategy Officer role would combine regulatory leadership, therapeutic development strategy, and enterprise-level risk oversight.

The executive would work across scientific, clinical, legal, quality, and commercial functions to align regulatory strategy with development priorities and business objectives. Responsibilities would include guiding regulatory pathways, evaluating development risks, and advising senior leadership on decisions affecting product advancement and long-term business performance.

Your experience as Vice President of Regulatory Affairs at BioTissue, together with your board positions at aidCure AG and Ardanza BioPharma, appears relevant to the blend of regulatory expertise, strategic judgment, and governance this type of executive position requires.

Key Responsibilities
Establish regulatory strategies aligned with therapeutic development objectives and corporate priorities.

Oversee regulatory planning across clinical development, product submissions, and lifecycle management.

Advise executive leadership on regulatory risks, development pathways, and strategic decisions.

Establish regulatory governance frameworks and risk mitigation processes.

Direct engagement strategies with relevant health authorities and external regulatory advisers.

Collaborate with clinical, medical, quality, manufacturing, and commercial teams to align development plans with regulatory requirements.

Assess regulatory implications of strategic partnerships, licensing arrangements, and portfolio expansion.

Provide executive-level insight into development milestones, regulatory exposure, and business risks.

Develop regulatory leadership capabilities, organizational effectiveness, and measurable performance standards.

Essential Qualifications & Experience
Significant senior leadership experience in regulatory affairs within biotechnology, biopharmaceuticals, or a related life sciences sector.

Demonstrated ownership of regulatory strategy, development planning, and complex regulatory risk decisions.

Experience advising executive leadership on strategic and operational priorities.

Strong understanding of regulatory frameworks governing clinical development and therapeutic products.

Ability to collaborate across scientific, commercial, operational, and governance functions.

Desirable Experience
Board or advisory board experience within biotechnology or life sciences.

Familiarity with international regulatory frameworks and cross-border development programs.

Experience supporting strategic partnerships, licensing transactions, or corporate development initiatives.

A track record of leading regulatory organizations through growth or portfolio expansion.

Compensation & Benefits
Base Salary: $350,000–$450,000 annually.

Executive Incentives: Performance-based annual bonus targeted at 40–60% of base salary.

Equity Participation: Potential long-term equity incentives linked to company performance and value creation.

Benefits: Executive healthcare coverage, wellness programs, and enhanced paid leave.

Retirement: 401(k) with employer contribution, subject to plan terms.

Work Model: Hybrid in Cambridge, Massachusetts, with business travel as required.