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Full-Time

Senior Director

Regulatory Strategy & Global Resilience Initiatives

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Healthcare
Biotechnology

Senior

London, UK

70% in-office structure.

Category
Healthcare Administration & Support
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Communications
Requirements
  • Degree in Life Sciences or related discipline, advanced degree preferred (PharmD, MSc, PhD).
  • 12+ years of experience in the pharmaceutical industry; 8+ years of experience in Global Regulatory CMC strategy.
  • Good knowledge of current international regulations related to GMP manufacturing, licensing, and overall quality principles for innovative medicines, including mRNA technology and gene therapy requirements.
  • Experience and good understanding of Module 3 content of regulatory submissions.
  • Experience and good understanding of UK Regulators, government agencies, and the NHS.
  • Experience with manufacturing process tech transfers and registration of new manufacturing sites.
  • Strong project management and analytical skills.
  • Ability to bring together various stakeholders and to reconcile different perspectives and priorities.
  • Ability to work independently to manage multiple projects in a fast-paced environment.
  • Self-starter with a high level of sense of accountability and ownership on assigned projects.
  • Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones.
  • Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.
Responsibilities
  • Develop and contribute to the consolidated regulatory deliverables plan for Project Resilience.
  • Work closely with the Country Regulatory Leads in the Project Resilience markets to ensure the robustness and timeliness of regulatory plans, and the execution and coordination of the overall GRS activities for Project Resilience among GRS line functions at the HQ, regional, and country levels.
  • Maintain the regulatory progress on the Project Resilience Global Score Card.
  • Communicate and present to management all relevant regulatory updates/requests/risks and potential delays.
  • In collaboration with GRS HQ and Country Regulatory Leads, identify and assess Project Resilience regulatory risks, coordinate and prepare risk register and corresponding mitigation plans.
  • Support the execution of the specific Project Resilience GRS deliverables such as Health Authority interactions, submission planning and approval tracking, and cross-functional projects involving Quality, Manufacturing, and Site Leadership.
  • Coordinate regulatory activities with external partners and stakeholders, ensuring alignment and compliance with local and international regulations.
  • Develop and maintain strong relationships with regulatory agencies, government officials, and key stakeholders to facilitate smooth regulatory processes.
  • Oversee the preparation and submission of regulatory documents and applications to Health Authorities, ensuring accuracy, completeness, and timeliness.
  • Lead and manage regulatory inspections and audits, ensuring readiness and compliance across all Project Resilience sites.
  • Provide timeline updates to GRS LT and raise Project Resilience topics relevant for endorsement, discussion, or decision.
  • Prepare and deliver effective communications and presentations for external and internal audiences.
  • Integrate and manage the UK-specific aspects of the role, ensuring 40-50% of the responsibilities are focused on UK-specific regulatory activities and 50% on the integration of Resilience sites to consolidate best practices and processes.
  • Mentor and guide junior regulatory staff, fostering a collaborative and high-performance culture within the regulatory team.
  • Monitor regulatory developments and trends that may impact Project Resilience, advising on necessary adjustments to strategies and plans.
  • Ensure all regulatory activities are conducted in accordance with Moderna’s policies, SOPs, and ethical standards.

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.