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Regulatory Affairs Associate

1 month ago

Mississauga, Canada AstraZeneca Full time

**Regulatory Affairs Associate**

**Hybrid Work
- on average 3 days/week from office**

**Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office**

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**Summary**:
**Typical Accountabilities**:

- Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
- Working with setting up submissions in Electronic Regulatory Vault (ERV)
- Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
- Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals.
- Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation
- Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser
- Provide coaching, mentoring and knowledge sharing within the RPM skill group
- Contribute to process improvement

**Essential Requirements**:

- Excellent written and verbal communication skills
- Organized with project management skills
- Experience in document management and tracking databases
- Aptitude to learn new systems quickly
- Cultural awareness
- Proficiency with common document management tools
- Ability to work independently and as part of a team
- Continuous improvement and knowledge sharing focused

**Desired Qualifications**:

- Relevant qualification and/or experience in science, administration or IT
- 1-6 years of revant experience from biopharmaceutical industry, or other relevant experience
- Experience with Veeva Vault
- Some regulatory/medical/technical experience
- Knowledge of AZ business and processes

**Great People want to Work with us Find out why**:

- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
- View our YouTube channel