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Full-Time

Director – Regulatory Strategy

Latent Viruses

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Healthcare
Biotechnology

Senior, Expert

Cambridge, MA, USA + 1 more

More locations: Bethesda, MD, USA

Candidate must be based in either Bethesda or Cambridge.

Category
Legal
Risk & Compliance
Legal & Compliance
Required Skills
Communications
Requirements
  • BA/BS degree in a scientific/engineering discipline. Advanced degree Preferred.
  • 10+ years of experience in the Pharmaceutical industry
  • 6+ years of experience in Regulatory strategy, including specifically: Vaccine Development
  • Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Infectious Disease vaccine programs.
  • Strong experience with CTD format and content of regulatory filings
  • Experience with developing and implementing competitive regulatory strategies
  • Demonstrated track record in maintaining a complex portfolio
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration,– preferably from at least both US and EU
  • Direct experience of leading regulatory authority meetings in different phases of drug development
  • Regulatory knowledge across therapeutic areas including infectious diseases and vaccine development is preferable.
  • Ability to work independently to manage multiple projects in a fast-paced environment.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones.
  • Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, the Project Team and senior management, as relevant.
  • Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.
Responsibilities
  • Serve as global regulatory lead accountable for all regulatory aspects of Latent Viruses vaccines, including development and implementation of the global regulatory strategy and plans.
  • Advise project teams regarding the development and implementation of regulatory strategy through all stages of the product’s development lifecycle.
  • Ensure the global regulatory strategy for assigned project(s) is aligned with the business objectives and have been negotiated with relevant health authorities as appropriate.
  • Ensure regulatory risk assessment and mitigation plans are developed and aligned across functions.
  • Set strategic direction and overall accountable for the preparation, submission, and follow-up of regulatory documents to health authorities for assigned program(s).
  • Liaise with health authorities, internal stakeholders, and external partners to ensure business objectives are achieved as defined.
  • Respond to requests for additional data, organize and manage participation in meetings. Negotiate directly and effectively with health agencies regarding company's filings.
  • Review and approve regulatory documents and dossiers prior to submission to regulatory authorities.
  • Support development and maintenance of the Target Label Profile and the Company Core Data Sheet for assigned program(s).
  • Monitor and interpret changes in the regulatory environment, especially related to the mRNA platform with focus on vaccine development, and communicate potential impact to internal teams.
  • Identify areas in need of improvement and lead the development and implementation of process improvements.
  • Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.

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 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

8%

2 year growth

55%
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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.