Job Description

The Role:
Reporting to the VP, CMC Regulatory Science, the Sr. Manager, CMC Regulatory Science-Canada will be based at the Canada site and as part of a team be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of mRNA products in Canada. This position will contribute to and support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Development of regulatory strategy for the products in our portfolio will be a key success component.
Here's What You'll Do:
Develop/implement effective CMC regulatory strategies for Canadian submissions (e.g. CTA/NDS/SNDS/NC), including all levels of post-Notice of Compliance quality change submissions and the Yearly Biologic Product Report (YBPR)
Provide guidance for regulatory CMC aspects of product development projects; identify local regulatory considerations
Develop, author and review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
Drive Regulatory CMC discussions and interactions with Health Canada to facilitate review and approval of submissions; act as a local submission lead for all CMC aspects of the dossier
Support the development of 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
Provides interpretation of regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
Collaborate closely with the Canadian Quality Assurance lead to prepare relevant submissions including the Drug Establishment License (DEL)
Here's What You'll Bring to the Table:
A BSc in life science or relevant scientific field (e.g. Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering)
A graduate degree and/or post-graduate certificate in Regulatory Science preferred
8+ years of experience in the pharmaceutical/biotech industry, with substantial experience in Biologics-focused Regulatory CMC
Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)
Strong knowledge of current Canadian Food & Drugs Act and regulations; US, EU and ROW experience an asset
Strong knowledge of cGMP
Experience with eCTD format and content regulatory filings
Exceptional written and oral communication skills
Good influencing, negotiation and relationship management skills
Demonstrated ability to develop effective regulatory CMC strategies that align to clinical considerations and commercial objectives
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary winter break
Educational resources
Savings and investments
Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .
Moderna is a smoke-free, alcohol-free and drug-free work environment.
#LI-JM2
-