Cmc Regulatory Affairs Manager, Submission

1 month 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.**:
**The Role**:
**Join us at AstraZeneca as a CMC Regulatory Affairs Manager Submission Excellence and Project Manager. In this role, you will manage all aspects related to the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will contribute and lead the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated.**:
**Accountabilities**:
**Essential Skills/Experience**:

- ** Bachelors degree in Science, Regulatory Sciences or Pharmacy.**:

- ** 2 years experience in Regulatory/Drug development (Industry or Health Authority)**:

- ** Breadth of knowledge of manufacturing, project, technical and regulatory management.**:

- ** IT Skills**:

- ** Stakeholder & Project management**:

- ** Professional capabilities: Regulatory knowledg**:
**Desirable Skills/Experience**:

- ** Masters degree in Science, Regulatory Sciences or Pharmacy**:

- ** 4 years experience in Regulatory/Drug development (Industry or Health Authority)**:

- ** Knowledge of the drug development process and regulatory submissions**:

- ** Understanding of current regulatory CMC requirements**:

- ** Direct/indirect** Regulatory Affairs CMC experience with clinical submissions for Synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or sophisticated biologic products**:

- ** Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies**:

- ** Lean capabilities**:
**At AstraZeneca, we are driven by innovation and originality. We work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We see change as an opportunity, embracing the possibility to learn, grow and evolve. We are striving for technology adoption and automation to drive efficiencies and new innovations. Here we have the ability and autonomy to be an agent of change.**:
**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**:
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