Regulatory Affairs Project Manager Cmc

5 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 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 Regulatory Affairs Project Manager, CMC will provide leadership on regulatory CMC matters to deliver efficient Health Canada approvals (time and quality), maintain compliance, and improve a product’s potential and lifecycle in the Canadian marketplace. Actively support the Regulatory Affairs department to maximize efficiency, performance and productivity. Role holder has an understanding of current regulatory CMC/DEL/Environmental regulations and requirements.

**Responsibilities**:

- Lead in the development and implementation of CMC, Establishment License (EL) and Environmental (NSN) submission and risk management strategies which will facilitate the review process with a strive to deliver Health Canada approvals in support of business objectives.
- Own the planning and execution of all activities associated with CMC-related Health Canada meetings including the development of supporting briefing materials and completion of post-meeting activities.
- Review chemistry and manufacturing documentation for compliance vs AZ standards, Health Canada regulations and ICH guidelines. Convey recommendations to management.
- Prepare and submit regulatory files (NDSs, SNDSs, NCs, Level III Changes, DEL and NSN submissions) in adherence with the Food and Drugs, Medical Device and Environmental Regulations, as appropriate, for submission to the Pharmaceutical Drugs Directorate (PDD), Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Environmental Assessment Unit and Health Products and Food Branch Inspectorate (HPFBI), Health Canada.
- Facilitate submission approvals through effective negotiation and communication with PDD, BRDD, and HPFBI.
- Maintain registration compliance for assigned projects to support ongoing manufacture and/or marketing of products in Canada.
- Lead or support therapeutic area projects/submissions as directed by Manager.
- Develop, foster and maintain positive relationships with all stakeholders involved in the lifecycle management of our brands.
- Help supervise changes to Regulatory environment (regulations, guidelines, policies, etc.) as advised by Manager.
- Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

**Essential**:

- B.Sc. or equivalent in a related (chemistry, health science) discipline. Advanced degree (M.Sc.) considered an asset as well as experience with Biologic and Establishment Licenses and drug product manufacturing.
- Previous experience in Regulatory Affairs mandatory.
- Current knowledge of cGXP’s (in particular cGMP, cGLP, cGCP), CMC Regulatory and ICH guidelines.
- Able to balance and progress multiple projects across all therapeutic areas.
- Proficient in the use of Microsoft Office and Veeva Vault platforms.
- Problem-solving ability and innovative thinking.
- Attention to detail, balanced with understanding of business objectives.

**Desirable**:

- Therapeutic area, product and brand knowledge
- Knowledge of AstraZeneca global and local policies and procedures
- Knowledge of international regulatory activities and trends

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
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