Sr. Manager, Regulatory Operations, Project Management

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The Role:This Regulatory Project Manager (RPM) is a regulatory specialist with project management expertise responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RPM contributes to regulatory submission planning, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RPM provides regulatory expertise and guidance on procedural and documentation requirements to GRA and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.Here’s What You’ll Do:

• Understand the regulatory framework, including regional trends, for various types of applications and procedures.
• Use and share best practices while operating in a highly dynamic environment Lead and / or contribute to the planning, preparation (where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinate the input, maintenance, and revision of project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner.
• Support operational and compliance activities for assigned deliverables, including generating work requests, submission content plans, and submission tracking.
• Support the programs on organizational process optimization (e.g Knowledge sharing).

Here’s What You’ll Bring to the Table:Minimum Requirements –Education And Experience

• BA/BS Degree in Science or related discipline or 5+ years relevant experience
• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• General knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams
• Strong communicator and team player

Preferred Experience

• Regulatory experience
• Managed regulatory deliverables at the project level
• Thorough knowledge of the drug development process
• Comfort working in a dynamic environment
• Prior experience with Veeva

Skills And Capabilities

• Cultural awareness
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (e.g., SmartSheet) and document management tools
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Continuous Improvement and knowledge sharing focused

Here’s What You’ll Do:

• Define, manage, and track specific deliverables needed for regulatory submissions working with cross-functional teams, including INDs/CTAs, BLAs/MAAs (Modules 1-5), meeting requests, briefing packages, responses to health authority requests, etc.
• Develop submission project timelines that identify key milestones to meet business objectives (e.g. from clinical trial initiation to regulatory submission and approval)
• Track and monitor timelines for key activities (e.g. database lock, document deliverables, authoring responses to health authority questions and meeting regulatory commitments).
• Ensure roles and responsibilities for project team members are clearly documented.
• Lead submission working group cross functional meetings to drive decision making and project execution.
• Ensure creation of agendas, meeting minutes, and tracking/resolution of action items.
• Proactively provide status updates to designated stakeholders via dashboards and milestone reports, and ensure leadership is aware of critical considerations.
• Ensure overall regulatory project timelines are aligned cross-functionally and support the coordination of timely regulatory submissions.
• Identify and recommend solutions for timeline concerns or obstacles, including risks and issues; engaging appropriate leads for mitigation and resolution, ensuring that all issues arrive at a conclusion or recommendation.
• May assist in management of special projects as needed, e.g. oversight of system/process improvement projects.

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

• BS degree in a scientific field with 8 years of experience in a biotechnology or pharmaceutical setting
• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• General knowledge of drug development
• Proven track record of successful project management experience supporting early- and late-stage and submission programs
• Leadership skills, including experience leading multi-disciplinary project teams
• Strong project management skills
• Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally
• Strong personal and leadership skills to influence without authority, motivate others and manage conflict
• Strong communicator and team player
• Strong working knowledge of MS Project, Smartsheet and timeline visualization software (i.e. One Pager, ThinkCell)
• Preferred: Project/program management training

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.About ModernaIn over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.Moderna is a smoke-free, alcohol-free and drug-free work environment.]]>