Cmc Ra Reg Associate Submission Excellence

3 months 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 build 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 crafted with teamwork 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 environment 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.

**Responsibilities**:

- Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
- Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.
- Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables.
- Develop research skills relevant information, regulations, and guidance from different regulatory agencies.
- Writing scripts and participating in system testing in support of system releases
- Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
- Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
- Ensure the learning from own projects are shared with other colleagues/within the functions.

**Education, Qualifications, Skills and Experience**
- Foundational / Associate degree in Science, Regulatory Sciences or Pharmacy
- Team working skills
- IT Skills
- Bachelors degree in Science, Regulatory Sciences or Pharmacy
- 1 year experience in Regulatory / Drug development (Industry or Health Authority)
- Basic Knowledge of the drug development process and regulatory submissions
- Understanding of current regulatory CMC requirements
- Experience in Pharmaceutical production, reg affairs, quality assurance, R&D
- Basic Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies

Great People want to Work with us Find out why:

- GTAA Top Employer Award for 9 years
- Learn about our culture
- Learn more about working with us in Canada
- View our YouTube channel

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