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

Bethesda, MD, USA

70% in-office presence required.

Category
Project Management
Legal & Compliance
Business & Strategy

You match the following Moderna's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
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.
  • 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.
  • 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.
  • 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.
  • Act as a liaison between the regulatory project management team and other departments, ensuring clear communication and optimal collaboration.
Desired Qualifications
  • Advanced degree preferred.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a molecule that provides instructions for cells to produce proteins essential for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to improve the discovery, development, and manufacturing of drugs. Unlike traditional methods that often rely on proteins or other compounds, Moderna's use of mRNA allows for a more direct and potentially more effective way to treat diseases. The company's goal is to harness the power of mRNA to create therapies that can significantly enhance patient health and address unmet medical needs.

Company Stage

IPO

Total Funding

$6.5B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

0%

1 year growth

2%

2 year growth

4%
Simplify Jobs

Simplify's Take

What believers are saying

  • Moderna secured a $590 million contract for bird flu vaccine development.
  • The EU awarded Moderna a tender for COVID-19 vaccine supply until 2029.
  • Moderna's mRNA technology is advancing in personalized cancer and HIV vaccines.

What critics are saying

  • Increased competition from Pfizer and BioNTech in the mRNA market.
  • Potential reduced demand for COVID-19 vaccines as the pandemic wanes.
  • Regulatory challenges may delay new mRNA vaccine approvals.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for a new class of medicines.
  • The company collaborates with Merck on personalized mRNA cancer vaccines.
  • Moderna is expanding mRNA applications to rare diseases and cardiovascular conditions.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

Sabbatical Leave

Hybrid Work Options

401(k) Company Match

Parental Leave

Family Planning Benefits

Fertility Treatment Support

Adoption Assistance

Wellness Program

Mental Health Support

Phone/Internet Stipend

Home Office Stipend