Regulatory Affairs Intern

**The Role**:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its presence in Toronto, Canada's largest city and a hub for biotech innovation. Our Toronto office focuses on commercial operations, ensuring the delivery of our innovative products to the Canadian market. We're inviting international talents to join our mission of transforming medicine and impacting lives worldwide.

As a Regulatory Affairs Intern, you will play a key supporting role in advancing regulatory approval initiatives for Moderna’s innovative mRNA medicines in Canada. This internship offers hands-on exposure to regulatory operations in a dynamic biotech environment, fostering professional growth and development. Working closely with Moderna's Canadian Regulatory Affairs team and strategic partners, you will contribute to a range of regulatory activities to ensure compliance with Health Canada’s evolving requirements.

This is a 4-month, full-time internship (40 hours/week), with the possibility of extension. The expected start date is April-May 2025. The internship will be based in Moderna’s Toronto office, with an expectation of at least 70% in-office presence.

**Here’s What You’ll Do**:
**Your key responsibilities will be**:

- 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.

**Here’s What You’ll Need (Basic Qualifications)**:

- Bachelor’s Degree in Science
- Current enrollment in a Master’s program or a relevant graduate certificate program related to Regulatory Affairs.

**Here’s What You’ll Bring to the Table (Preferred Qualifications)**:

- A passion for innovation and the potential of mRNA technology to transform medicine.
- Strong attention to detail and ability to solve problems and manage multiple priorities effectively.
- A proactive, self-starter attitude and the ability to maintain flexibility and agility in addressing new challenges or shifting priorities in a dynamic environment.
- Exceptional communication and collaboration skills to engage with cross-functional teams and external stakeholders.
- Familiarity with the drug development process and Health Canada’s regulations and guidelines
- A focus on learning to adapt and grow within the ever-evolving regulatory landscape, demonstrating curiosity and a commitment to continuous improvement.
- An ownership mindset, with a track record of taking accountability for deliverables and contributing meaningfully to a team’s success.
- Familiarity with Microsoft Office Suite (Word, Excel, PowerPoint) and digital collaboration tools. Experience leveraging generative AI tools a plus
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

**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 Spendi