Regulatory Affairs Analyst

2 weeks ago

Mississauga, Canada Novo Nordisk Full time

Regulatory Affairs Analyst

**Category**:Reg Affairs & Safety Pharmacovigilance

**Location**:Mississauga, Ontario, CA

**The Position**
- As a Regulatory Affairs Analyst, you will:

- Manage the preparation of mock-up and final product labelling artwork for regulatory submissions and compliance.
- Assess Health Canada regulations and guidelines to determine requirements for regulatory submissions and labelling changes.
- Utilize internal systems (e.g., Vault RIM) for managing regulatory activities and ensuring compliance.
- Handle annual notifications, change control assessments, and provide safety information as requested by Health Canada.

**Qualifications**
- Bachelor’s Degree required.
- Minimum 1+ years of hands-on experience in regulatory submission preparation.
- Experience in labelling, preparing clinical trials, and post-approval changes to marketing (Canadian experience preferred).
- Experience with eCTD preparation and some experience with a document management system.
- Good knowledge of Health Canada drug & device Regulations, guidances, and policies.
- 1-2 years of regulatory affairs experience.
- Nice to have:

- Knowledge in the biomedical or biology industry.

**About the Department**

**Working at Novo Nordisk**
- Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us Together, we go further. Together, we’re life changing.

**Contact**

**Deadline**
- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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