Full-Time

Director – Regulatory Project Management

Posted on 9/20/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

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 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 treating diseases. Unlike traditional pharmaceuticals, which often rely on small molecules or proteins, Moderna's mRNA-based therapies aim to enhance the speed and efficiency of drug discovery and manufacturing. The company's goal is to improve patient outcomes by harnessing the power of mRNA to create effective treatments for a range of health conditions.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

15%

2 year growth

48%
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Simplify's Take

What believers are saying

  • Moderna's AI-driven drug discovery accelerates novel mRNA-based therapeutics identification.
  • Expansion in Asia enhances global supply chain and reduces production costs.
  • mRNA technology is gaining traction for non-infectious disease vaccines, like cancer.

What critics are saying

  • Potential Nasdaq 100 removal could impact stock visibility and investor interest.
  • Bypassing safety steps in Australia may raise regulatory and public scrutiny concerns.
  • Hong Kong's reluctance to receive Covid-19 jab affects market penetration and sales.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for a new class of medicines.
  • The company focuses on mRNA's potential to transform drug discovery and manufacturing.
  • Moderna's mRNA platform enables rapid development of vaccines and therapeutics.

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