Full-Time

Director – Regulatory Strategy

Latent Viruses

Posted on 9/19/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

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
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 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 treatment options for patients. Unlike traditional pharmaceuticals, which often rely on small molecules or proteins, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to leverage the unique properties of mRNA to improve patient outcomes and create a new category of effective treatments.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

16%

2 year growth

55%
Simplify Jobs

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.

Help us improve and share your feedback! Did you find this helpful?

INACTIVE