Senior Manager, Regional Regulatory Project Management

Senior Manager, Regional Regulatory Project Management

Moderna

Warsaw, Poland

As the Sr. Manager of Regulatory Projects, you will provide forward-thinking leadership in overseeing the strategic and operational aspects of regulatory projects across the organization. Acting as a strategic partner, you will guide the development and execution of global regulatory plans that align with long-term business goals. This role requires a motivated, experienced Regional Regulatory Project Manager with the ability to lead complex projects, manage international regulatory strategies, and navigate diverse regulatory landscapes. Your expertise will ensure timely and compliant regulatory submissions, driving Moderna’s impact in multiple international markets.

Here's What You’ll Do:

Your key responsibilities will be:

• Lead and manage cross-functional teams to ensure the successful and timely completion of regulatory submissions and approvals.
• Develop and oversee project plans, encompassing timelines, milestones, resources, and budgets, to facilitate efficient regulatory approval processes.
• Monitor project progress, addressing deliverables, potential roadblocks, and delays effectively.
• Analyze regulatory requirements across jurisdictions and provide actionable guidance to internal stakeholders.

Your responsibilities will also include:

• Manage the preparation, submission, and approval of regulatory documentation for international markets (EMA, MHRA, etc.).
• Coordinate with regulatory bodies, consultants, and vendors to streamline submission and approval processes.
• Ensure the accuracy, completeness, and consistency of regulatory documents and submissions.
• Collaborate with cross-functional teams, including R&D, legal, marketing, quality assurance, and clinical affairs, to align regulatory requirements with product development and marketing strategies.
• Maintain regulatory records and files, ensuring compliance with internal and external standards.
• Promote continuous improvement by identifying efficiencies in regulatory processes and sharing best practices across the organization.

Here’s What You’ll Bring to the Table:

• Bachelor’s degree with minimum of 7 years of experience leading regulatory submissions and or strong program management experience in a hands-on and strategic capacity.
• Proven ability to act as a forward-thinking leader, capable of planning ahead and identifying strategic pathways in regulatory operations.
• Extensive cross-functional project management experience, with a track record of making progressive and impactful decisions.
• Strong understanding of drug development, clinical study processes, and regulatory submissions, with the ability to address both the day-to-day and long-term strategic aspects.
• Expertise in ensuring compliance with cGMP and managing complex regulatory submissions across global markets.
• Demonstrated ability to lead teams effectively, manage multiple complex projects simultaneously, and contribute to the broader strategic direction of the organization.

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