Sr. Director, Global Regulatory Strategy, Oncology

Moderna; Cambridge (MA); On-site; USD 250,000 - 350,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family planning benefits

Generous paid time off

Job summary

Moderna Therapeutics in Cambridge, MA seeks a Sr. Director of Regulatory Strategy to lead regulatory planning for oncology programs and to shape global regulatory strategies for a novel mRNA platform.

You will direct submissions, coordinate with health authorities, manage teams, and align with business objectives while navigating US/EU regulations and CTD requirements.

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/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 of securing product approvals in a complex portfolio.

Responsibilities

• Set strategic direction for regulatory submissions and amendments.
• Advise project teams on regulatory strategy through development processes.
• Maintain relationships with global health agencies.
• Coordinate meetings and negotiate with health authorities.
• Review technical data and ensure accuracy for regulatory filings.
• Develop and review policies compliant with regulatory agencies.
• Provide input on trials and filing activities to ensure compliant reporting systems.
• Monitor regulatory publications to anticipate changes and impacts.
• Lead global regulatory development plans and align with business objectives.

Skills

Communication

Regulatory strategy

Stakeholder management

Leadership

CTD experience

Regulatory submissions

Education

Bachelor’s degree in science/engineering

Graduate degree or professional certification

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. That's why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.

• 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, a