Full-Time

Senior Director

Regulatory Strategy & Global Resilience Initiatives

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

London, UK

70% in-office structure.

Category
Healthcare Administration & Support
Physicians & Surgeons
Medical, Clinical & Veterinary
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.
  • A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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 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%
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Simplify's Take

What believers are saying

  • Opening a new vaccine facility in Victoria enhances manufacturing capabilities.
  • Strategic investment in China boosts Moderna's presence in the Asian market.
  • Collaboration with Carisma Therapeutics could lead to breakthroughs in autoimmune treatments.

What critics are saying

  • Potential removal from Nasdaq 100 could impact investor perception.
  • Reticence in Hong Kong for Covid-19 jab indicates market penetration challenges.
  • Expansion into China may expose Moderna to geopolitical and regulatory risks.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for innovative medical treatments.
  • The company has a strong focus on developing vaccines for infectious diseases.
  • Moderna's mRNA platform enables rapid development of therapeutics and vaccines.

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