Regulatory Affairs Associate

3 weeks ago

Mississauga, Canada AstraZeneca Full time

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 and BlueSky Hub in downtown Toronto are 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.

**Description**

**Accountabilities/Responsibilities**
- Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements.
- Planning, preparing and implementing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
- Connect 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 RAM skill group.
- Contribute to process improvement.

**Minimum Requirements**
- Relevant qualification and/or experience in science, administration or IT
- Confirmed experience from biopharmaceutical industry, or other proven experience
- Proficient verbal and written English
- Project Management skills
- Experience in document management and tracking databases

**Preferred Experience**
- Some regulatory/medical/technical experience
- Knowledge of AZ business and processes
- Some knowledge of AZ submission, compilation, publishing and approval processes, standards, systems and tools

**Skills and Capabilities**
- Good written and verbal communication skills
- Cultural awareness
- Proficiency with common document management tools
- Ability to work independently and as part of a team
- Continuous Improvement and knowledge sharing focused

**Great People want to Work with us Find out why**:
AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is a crucial requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

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