Simplify Logo

Full-Time

Director – Global Regulatory Science CMC

Oncology

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Healthcare
Biotechnology

Senior

Norwood, MA, USA

Category
Risk & Compliance
Legal & Compliance
Required Skills
Communications
Requirements
  • Bachelor’s degree in a scientific/engineering discipline
  • 12+ years of experience in the pharmaceutical/biotech industry
  • 8 + years of experience in Regulatory CMC
  • Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions
  • Strong knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance
  • Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
  • Prior management experience required
  • Excellent interpersonal skills for internal and external negotiation and influence
  • Exceptional written and oral communication skills
Responsibilities
  • Develop/implement effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
  • Provide guidance for regulatory CMC aspects of product development projects
  • Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
  • Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
  • Develop regulatory processes and procedures to support CMC components of regulatory submissions
  • Support the creation and maintenance of CMC submission templates
  • Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls
  • Perform assessment of manufacturing change controls
  • Provide interpretation of regulatory guidance documents, regulations, and directives – advise Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
  • Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)

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%
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.