Overview In this role, you will lead the regulatory strategy for oncology programs at Moderna, shaping global plans to secure market authorization for an innovative mRNA modality. You will partner with cross-functional teams and engage global health authorities to anticipate risks and opportunities, guiding submissions and regulatory decisions. As a regulatory strategic leader, you will influence trials, filings, and policy development while ensuring alignment with business goals. You will operate at the intersection of science, strategy, and regulation to drive product approvals and portfolio success.
Compensation / Benefits- Competitive healthcare
- Well-being resources (fitness, mindfulness, mental health)
- Family planning benefits
- Generous paid time off
- Discretionary bonus eligibility
- Equity award potential
Responsibilities- Set strategic direction for regulatory submissions and related amendments
- Advise on regulatory strategy throughout clinical and nonclinical development
- Maintain strong relationships with global health authorities
- Lead meetings and negotiate with health authorities on filings
- Review and approve regulatory data and ensure regulatory compliance of clinical projects
- Develop and update regulatory policies to comply with US and international agencies
- Act as regulatory affairs executive to oversee trials and filing activities
- Monitor regulatory publications for developments and impact
- Ensure Target Label Profile and Company Core Data Sheet are maintained
- Collaborate with internal teams and partners on submissions to authorities
- Serve as global regulatory lead for assigned projects and develop global regulatory development plans
- Align global regulatory strategy with business objectives and negotiate with authorities as needed
- Possibly manage direct reports and drive process improvements
- Allocate regulatory resources and budgets to deliver project milestones
Key requirements- 12+ years in the pharmaceutical industry
- 8+ years in regulatory strategy, including oncology
- Strong knowledge of US and EU regulations, including novel regulatory pathways
- Experience with CTD format and regulatory filings
- Excellent written and oral communication
- Track record in securing approvals and managing a complex portfolio
- Experience engaging stakeholders at multiple levels
- Experience leading regulatory authority meetings across phases of development
- Knowledge of drug development regulatory procedures and legislation in US and EU
- Direct experience with line management and development of staff
- Strategic thinking
- Executive communication
- Relationship-building with regulators
- CTD format and content
- Regulatory submissions management
- Global regulatory development planning
