- Assist in regulatory submissions by supporting the preparation of Supplemental New Drug Submissions, Notifiable Changes, and Level III Changes, as well as responses to Health Canada queries.
- Track and document regulatory activities to maintain a comprehensive and up-to-date regulatory history.
- Monitor evolving Health Canada regulations and contribute to internal documentation updates as needed.
- Collaborate with cross-functional teams to support the timely and effective delivery of regulatory submissions.
- Gain insight into regulatory policies and procedures, particularly in the context of innovative technologies such as mRNA medicines.
Your Responsibilities Will Also Include
- Supporting digital initiatives to streamline regulatory processes and enhance engagement through a “Digital First” mindset.
- Attending relevant meetings and discussions to develop a deeper understanding of regulatory affairs in a biotech setting.
The key Moderna Mindsets you’ll need to succeed in the role:
- We obsess over learning – This role requires a strong curiosity and eagerness to understand complex regulatory processes and novel mRNA technologies in a rapidly evolving regulatory landscape .
- We digitize everywhere possible – You will contribute to Moderna’s digital-first approach by supporting digital initiatives aimed at improving engagement, tracking regulatory activities, and streamlining submission processes .
