Associate Director, Regulatory Strategy & Global Resilience Initiatives at Moderna

London, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Understanding of various development and registration activities in local Resilience countries (e.g., UK, Canada, Australia)
Awareness of interdependencies between Portfolio timelines and Resilience manufacturing site timelines
Key Moderna Mindsets: Prioritize the platform (align strategic goals of Project Resilience with Moderna’s platform objectives) and Act with urgency (rapidly address regulatory challenges and make swift decisions)

Responsibilities

Contribute to the consolidated regulatory deliverables plan for Project Resilience
Work closely with Country Regulatory Leads in Project Resilience markets to ensure robustness and timeliness of regulatory plans
Execute and coordinate overall GRS activities for Project Resilience among GRS line functions at HQ, regional, and country levels
In collaboration with GRS HQ and Country Regulatory Leads, identify and assess Project Resilience regulatory risks, coordinate and prepare risk register, potential delays, and corresponding mitigation plans
Coordinate regulatory activities with external partners and stakeholders, ensuring alignment and compliance with local and international regulations
Assist in preparation of regulatory documents and applications to Health Authorities, ensuring accuracy, completeness, and timeliness
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 UK-specific aspects of the role (40-50% focus on UK-specific regulatory activities and 50% on integrating 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

Skills

Key technologies and capabilities for this role

Regulatory StrategyRegulatory AffairsPharmaceutical ManufacturingFacility LicensureRegulatory ApprovalsmRNA TechnologyQuality AssuranceProject Management

Questions & Answers

Common questions about this position

What is the employment type for this role?

This is a full-time position.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What key responsibilities does this role involve?

The role involves leading regulatory deliverables for Project Resilience across sites like UK, Canada, and Australia, contributing to regulatory plans, assessing risks, coordinating with Country Regulatory Leads and external partners, and preparing regulatory documents.

What is the company culture like at Moderna?

Moderna offers a pioneering team environment revolutionizing medicine through mRNA technology, working alongside exceptional colleagues and strategic partners worldwide in a continually growing organization committed to advancing mRNA medicines and global health initiatives.

What makes a strong candidate for this Associate Director role?

A strong candidate will have expertise in regulatory strategy, understanding of development and registration activities in countries like UK, Canada, and Australia, experience with regulatory risk assessment, coordination across HQ, regional, and country levels, and skills in preparing regulatory documents for Health Authorities.

Moderna

Develops mRNA-based medicines for health

About Moderna

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for 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 treating diseases. Unlike traditional pharmaceuticals, which often rely on chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to improve patient outcomes by harnessing the power of mRNA to create effective treatments.

Cambridge, MassachusettsHeadquarters

2010Year Founded

$5,925.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

5,001-10,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

Sabbatical Leave

Hybrid Work Options

401(k) Company Match

Parental Leave

Family Planning Benefits

Fertility Treatment Support

Adoption Assistance

Wellness Program

Mental Health Support

Phone/Internet Stipend

Home Office Stipend

Risks

Potential backlash in Australia for bypassing vaccine safety steps.

Possible removal from Nasdaq 100 Index could affect investor confidence.

Hong Kong residents' reluctance to get vaccinated may hinder market penetration.

Differentiation

Moderna is pioneering mRNA technology for new categories of medicines.

The company integrates AI to optimize mRNA design and production processes.

Moderna's mRNA platform enables rapid development of vaccines and therapeutics.

Upsides

Moderna received a $176 million contract for a bird flu vaccine.

The company is expanding mRNA applications to personalized cancer vaccines.

Moderna is establishing a domestic mRNA production facility in Australia.

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