Full-Time

Senior Director

Regulatory Project Management

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior, Expert

Cambridge, MA, USA + 1 more

More locations: Bethesda, MD, USA

70/30 work model requires 70% in-office presence.

Category
Project Management
Legal & Compliance
Business & Strategy
Requirements
  • Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.
  • Minimum of 8 years of experience in regulatory affairs or project management within the pharmaceutical/biotechnology industry, including 3+ years in a leadership role.
  • Expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines.
  • Demonstrated experience in building and leading high-performing project management teams.
  • Strong organizational, communication, and problem-solving skills, with a focus on continuous improvement.
Responsibilities
  • Establish a robust regulatory project management framework, incorporating industry best practices, tools, and processes.
  • Design and implement training programs to enhance the team’s project management skills and regulatory knowledge.
  • Develop resource management and planning capabilities to support scalability and project efficiency across the organization.
  • Resourcing model for deployment of RPMs to drug projects.
  • Lead, mentor, and support a team of regulatory project managers, setting performance standards and development goals.
  • Conduct regular performance evaluations, offering guidance and support for career growth and technical skill enhancement.
  • Oversee resource allocation to balance team workloads and optimize project delivery.
  • Guide the team in defining regulatory project strategies, ensuring alignment with company objectives and regulatory timelines.
  • Oversee preparation and submission of regulatory filings (e.g., INDs, NDAs, MAAs) to ensure compliance and timely delivery.
  • Serve as an escalation point for complex regulatory challenges, providing direction to project managers as needed.
  • Ensure adherence to FDA, EMA, ICH, and other global regulatory standards across all projects.
  • Drive the implementation of best practices for regulatory project management, maintaining consistency and efficiency.
  • Monitor regulatory landscape changes, updating team processes and training to align with evolving guidelines.
  • Act as a liaison between the regulatory project management team and other departments, ensuring clear communication and optimal collaboration.
  • Provide regular updates to senior management on project timelines, risks, and achievements.
  • Lead cross-functional meetings to facilitate project progress and stakeholder alignment.
  • Identify and implement process improvements to enhance regulatory project management efficiency. Including identification of digital tools for RPM and submission efficiency and acceleration. (KPIs)
  • Regularly review team performance metrics and outcomes, adjusting strategies as needed to improve efficiency and quality.
  • Stay current with industry trends, sharing insights with the team to drive continuous improvement.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for patients. Unlike traditional pharmaceuticals, which often rely on chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to harness the power of mRNA to improve patient outcomes and create effective treatments for a range of diseases.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

16%

2 year growth

55%
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Simplify's Take

What believers are saying

  • mRNA technology is expanding into personalized cancer vaccines, revolutionizing treatment.
  • Recent advancements in lipid nanoparticle delivery enhance mRNA vaccine efficacy.
  • Global mRNA vaccine market projected to grow significantly, boosting Moderna's prospects.

What critics are saying

  • Potential exclusion from Nasdaq 100 could impact investor perception and liquidity.
  • Bypassing safety steps in Australia may raise regulatory scrutiny.
  • Geopolitical tensions in China pose operational and financial risks for Moderna.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for a new class of medicines.
  • The company has developed one of the earliest and most effective COVID-19 vaccines.
  • Moderna's mRNA platform enables rapid development of vaccines for various diseases.

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