Director of Regulatory Affairs
EnergyHubSalary not specified
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
YesVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Deep expertise in Canadian regulatory pathways
- Experience with Health Canada submissions (CTAs, NDSs, SNDSs, post-NOC submissions, meeting packages)
- Ability to lead and manage regulatory strategy for mRNA medicines or novel drug modalities
- Strong cross-functional collaboration skills with global teams
- Experience mentoring junior regulatory professionals
- Proactive leadership mindset, embracing digital tools (including Generative AI) and ownership beyond job description
- Based in Toronto, Canada
Responsibilities
- Provide regulatory leadership across Canadian filings, ensuring alignment with cross-functional and global partners
- Drive Canadian regulatory strategy in collaboration with Global Regulatory Science, integrating local requirements into development and commercialization
- Oversee preparation and execution of regulatory submissions including CTAs, NDSs, SNDSs, post-NOC submissions, and Health Canada meeting packages
- Serve as primary liaison with Health Canada for assigned projects, engaging to support successful outcomes and resolve complex issues
- Mentor junior regulatory professionals, promoting continuous learning and leadership development
- Maintain strategic oversight of regulatory labeling activities (Product Monographs, packaging), ensuring alignment with global positioning and compliance
- Lead regulatory intelligence gathering and competitive landscape assessments to anticipate opportunities and risks
- Shape regulatory engagement strategy for projects from clinical through commercial stages
- Foster strong internal collaboration to align regulatory deliverables with Canadian and global objectives
- Contribute to a forward-looking regulatory culture, proactively engaging with Health Canada and positioning Moderna as a leader in regulatory innovation
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this role remote or based in a specific location?
The role is based in Toronto, Canada, at Moderna's office which focuses on commercial operations.
What are the key responsibilities of this role?
Key responsibilities include providing regulatory leadership for Canadian filings, driving regulatory strategy with global partners, overseeing submissions like CTAs, NDSs, and SNDSs, serving as liaison with Health Canada, and mentoring junior staff.
What expertise is required for this position?
The role requires deep expertise in Canadian regulatory pathways, experience with Health Canada submissions such as CTAs, NDSs, and SNDSs, and skills in regulatory strategy for mRNA medicines.
What is the company culture like at Moderna?
Moderna offers an environment rich with innovation, autonomy, and global collaboration, where employees work alongside exceptional colleagues and strategic partners worldwide on pioneering mRNA technology.
What makes a strong candidate for this role?
A strong candidate is a forward-thinking regulatory professional with deep expertise in Canadian regulatory pathways, experience leading Health Canada submissions, and the ability to collaborate cross-functionally and mentor junior staff.
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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