Moderna Therapeutics Inc.
VP, Regulatory Affairs, Oncology & INT
Moderna Therapeutics Inc., Cambridge, Massachusetts, us, 02140
The Role:As VP of Regulatory Affairs for Oncology and INT, you will lead and develop the regulatory strategy for Moderna’s oncology and individualized neoantigen therapies programs. You will work collaboratively to articulate clear and compelling regulatory strategies, highlighting risks and opportunities, and leveraging the mRNA platform technology. Your leadership will be pivotal in navigating the complex interplay between the FDA, EMA, and other international health agencies, ensuring successful registration and commercialization of oncology and INT products.
Here’s What You’ll Do:Strategic Leadership: Design and execute the strategic vision for regulatory affairs in Oncology and INT, ensuring alignment with Moderna’s global business objectives.
Regulatory Submissions: Oversee the preparation, submission, and approval processes for regulatory filings, including IND amendments and supplements.
Regulatory Compliance: Monitor regulatory developments and provide guidance to project teams regarding the implementation of regulatory strategies.
Agency Interaction: Establish and maintain relationships with regulatory agencies, respond to requests for additional data, and negotiate with regulatory authorities.
Policy Development: Develop and implement regulatory policies and practices in compliance with federal and international guidelines.
Team Leadership: Manage and develop a high-performing regulatory team, ensuring the team is equipped to meet regulatory milestones.
Cross-functional Collaboration: Partner with internal teams and external partners to manage submissions and ensure regulatory compliance.
Global Regulatory Lead: Serve as the global regulatory lead, accountable for all regulatory aspects of assigned projects, including the development and implementation of global regulatory development plans.
Communication: Effectively communicate regulatory strategies, risks, and plans to the GRS, project development teams, and senior management.
Resource Management: Ensure appropriate levels of resources and manage the regulatory budget.
Continuous Improvement: Identify and implement process improvements to enhance regulatory practices.
Here’s What You’ll Bring to the Table:BA/BS degree in a scientific/engineering discipline required; Masters or PhD preferred.
Minimum of 15 years of regulatory experience in biotech, pharma, or clinical research organizations, with 12+ years in regulatory strategy.
In-depth knowledge of relevant FDA, EU, ICH guidelines, and regulations, particularly for oncology and individualized therapies.
Proven experience with regulatory filings and negotiations with FDA and international health authorities.
Excellent communication skills and the ability to convey complex regulatory issues clearly.
Strong leadership and team management skills.
Ability to work independently and manage multiple projects in a fast-paced environment.
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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Here’s What You’ll Do:Strategic Leadership: Design and execute the strategic vision for regulatory affairs in Oncology and INT, ensuring alignment with Moderna’s global business objectives.
Regulatory Submissions: Oversee the preparation, submission, and approval processes for regulatory filings, including IND amendments and supplements.
Regulatory Compliance: Monitor regulatory developments and provide guidance to project teams regarding the implementation of regulatory strategies.
Agency Interaction: Establish and maintain relationships with regulatory agencies, respond to requests for additional data, and negotiate with regulatory authorities.
Policy Development: Develop and implement regulatory policies and practices in compliance with federal and international guidelines.
Team Leadership: Manage and develop a high-performing regulatory team, ensuring the team is equipped to meet regulatory milestones.
Cross-functional Collaboration: Partner with internal teams and external partners to manage submissions and ensure regulatory compliance.
Global Regulatory Lead: Serve as the global regulatory lead, accountable for all regulatory aspects of assigned projects, including the development and implementation of global regulatory development plans.
Communication: Effectively communicate regulatory strategies, risks, and plans to the GRS, project development teams, and senior management.
Resource Management: Ensure appropriate levels of resources and manage the regulatory budget.
Continuous Improvement: Identify and implement process improvements to enhance regulatory practices.
Here’s What You’ll Bring to the Table:BA/BS degree in a scientific/engineering discipline required; Masters or PhD preferred.
Minimum of 15 years of regulatory experience in biotech, pharma, or clinical research organizations, with 12+ years in regulatory strategy.
In-depth knowledge of relevant FDA, EU, ICH guidelines, and regulations, particularly for oncology and individualized therapies.
Proven experience with regulatory filings and negotiations with FDA and international health authorities.
Excellent communication skills and the ability to convey complex regulatory issues clearly.
Strong leadership and team management skills.
Ability to work independently and manage multiple projects in a fast-paced environment.
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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