Global Oncology Regulatory Strategy Lead

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

Job summary

Moderna Therapeutics, headquartered in Cambridge, MA, seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for oncology programs leveraging mRNA technology.

This senior role requires strategic leadership to navigate US/EU paths and interactions with health authorities to enable timely approvals. In this position you will set regulatory direction, supervise submissions, manage agency negotiations, and drive policy updates.

Qualifications

• 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 novel regulatory pathways.
• Strong experience with CTD format and content regulatory filings.
• Exceptional written and oral communication.
• Experience developing and implementing competitive regulatory strategies.
• Track record in securing product approvals and managing a complex portfolio.

Responsibilities

• Sets strategic direction and leads regulatory submissions and related content.
• Advises on development of regulatory strategy through clinical and nonclinical development.
• Maintains excellent relationships with global health agencies.
• Negotiates with health agencies regarding filings and manages data requests.
• Reviews data and ensures accuracy of regulatory submissions.
• Develops and updates regulatory policies to comply with global agencies.
• Serves as regulatory affairs executive guiding trials and filing activities.
• Monitors regulatory publications for impact on projects.
• Manages global regulatory development plans and alignment with business goals.
• Leads process improvements and resource management for regulatory deliverables.

Skills

Regulatory strategy

Oncology

US/EU regulations

Regulatory submissions

Education

BA/BS in science/engineering

Graduate degree preferred

Job description

Moderna Therapeutics, headquartered in Cambridge, MA, seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for oncology programs leveraging mRNA technology.

This senior role requires strategic leadership to navigate US/EU paths and interactions with health authorities to enable timely approvals. In this position you will set regulatory direction, supervise submissions, manage agency negotiations, and drive policy updates.