Cmc Ra Reg Manager Submission Excellence and

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 holders project lead all aspects related to the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs of both the AZ business and the customer, including publishing of clinical and marketing regulatory documents. They project lead global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will chip in and lead the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with collaborators and project team members to ensure relevant timelines and regulatory commitments are communicated.

**Additionally you will**:

- Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.
- Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.
- Leads/represents PT&D and Pharm Sci on cross-functional work streams
- Documenting maintenance and communication of Health Authority approval status
- Gives advice, trains and mentors other team members.
- Raise change requests (ANGEL), manage, escalate & input into the cross functional vote.
- Continually evolve and develop the regulatory expertise through proactive recording and communications of Health Authority interactions, responses and commitments.
- Responsibility for change management as assigned.
- Demonstrate research skills in understanding regulations, and guidance from different regulatory agencies

**Minimum Qualifications**:

- University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
- Breadth of knowledge of manufacturing, project, technical and regulatory management.
- IT Skills
- Stakeholder & Project management
- Professional capabilities: Regulatory knowledge

**Preferred Qualifications**:

- Knowledge of the drug development process and regulatory submissions
- Understanding of current regulatory CMC requirements
- Direct/indirect Regulatory Affairs CMC experience with 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

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