Qualifications
Responsibilities
Benefits
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.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
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