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

The job requires a 70/30 in-office work model.

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 crucial component in how cells produce proteins necessary for 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 various diseases. Unlike traditional pharmaceuticals that often rely on proteins or antibodies, Moderna's mRNA-based therapies can be designed and manufactured more rapidly, allowing for quicker responses to emerging health challenges. The company's goal is to harness the power of mRNA to improve patient outcomes and transform the landscape of medicine.

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 awarded $590 million for bird flu vaccine development.
  • Moderna's mRNA technology expands into oncology and rare diseases.
  • Moderna's EU tender diversifies COVID-19 vaccine supply.

What critics are saying

  • Increased competition from BioNTech and Pfizer in mRNA vaccines.
  • Potential public skepticism reduces COVID-19 vaccine demand.
  • Regulatory challenges in obtaining approvals for new mRNA vaccines.

What makes Moderna unique

  • Moderna is pioneering mRNA as a new class of medicines.
  • Moderna's mRNA platform enables rapid development of vaccines and therapeutics.
  • Moderna's collaboration with AI firms enhances drug discovery processes.

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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