Full-Time

Director – Regulatory Project Management

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines and therapies

Biotechnology
Healthcare

Senior, Expert

Cambridge, MA, USA

Expected to be in office 70% of the time with flexibility to work from home up to 30%.

Category
Project Management
Legal & Compliance
Business & Strategy
Requirements
  • Bachelor’s degree with 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.
Responsibilities
  • Act as a forward-thinker and strategic partner in the development and implementation of comprehensive global regulatory plans that align with broader organizational objectives.
  • Identify innovative pathways and solutions to overcome regulatory challenges and streamline submission processes.
  • Lead and guide cross-functional teams to ensure the successful execution of regulatory submissions, meeting key milestones, timelines, and strategic goals.
  • Collaborate closely with senior leadership to provide forward-looking insights, ensuring that all regulatory projects are aligned with the company’s long-term vision.
  • Drive continuous process improvements that enhance both the productivity and strategic alignment of regulatory operations.
  • Strategic partners to Global Regulatory Lead(s) and Country Regulatory Leads to drive sub-team meetings (team alignments, strategy overview, and decision making).
  • Make progressive, decisive decisions to resolve complex regulatory challenges, providing innovative solutions to remove obstacles and delays.
  • Provide regular updates on project/submission/portfolio performance through dashboards and reports, ensuring senior management remains informed of both operational details and the broader strategic impact.
  • Support and implement risk mitigation strategies to ensure compliance with both internal and external regulatory requirements.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial molecule that provides instructions for cells to produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to potentially enhance the discovery, development, and manufacturing of drugs. Unlike traditional methods, which often rely on proteins or other biological materials, Moderna's use of mRNA allows for a more versatile and efficient way to create treatments. The company's goal is to improve patient outcomes by harnessing the power of mRNA to address a wide range of health issues.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

12%

2 year growth

54%
Simplify Jobs

Simplify's Take

What believers are saying

  • Moderna's expansion into combination vaccines and autoimmune therapies showcases its potential for diversified revenue streams and market leadership.
  • The company's continuous innovation and FDA approvals for updated COVID-19 vaccines highlight its resilience and adaptability in a rapidly changing market.
  • Moderna's educational initiatives, like the free mRNA course, position it as a thought leader and advocate for mRNA technology.

What critics are saying

  • The collapse in demand for COVID-19 vaccines could significantly impact Moderna's revenue and growth prospects.
  • Ongoing class action lawsuits alleging securities fraud could damage Moderna's reputation and financial stability.

What makes Moderna unique

  • Moderna is pioneering the use of mRNA technology to create a new class of medicines, setting it apart from traditional pharmaceutical companies.
  • The company's focus on mRNA as the 'software of life' allows for rapid development and manufacturing of vaccines and therapies, unlike conventional methods.
  • Moderna's ability to secure regulatory approvals for mRNA vaccines beyond COVID-19, such as for RSV, demonstrates its leadership in mRNA technology.

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