Regulatory Affairs Intern
Moderna Therapeutics
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See open jobs at Moderna Therapeutics.See open jobs similar to "Regulatory Affairs Intern" Greatness.bio.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 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 year-end shutdown
- 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
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should
contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com.
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This job is no longer accepting applications
See open jobs at Moderna Therapeutics.See open jobs similar to "Regulatory Affairs Intern" Greatness.bio.