Job Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 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\xe2\x80\x99re 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.They will ensure the application of global CMC regulations and guidance within AstraZeneca and lead/contribute to development of new mentorship, policy, and processesAdditionally you will:

• Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; including clinical programs, marketing authorisation applications and all post approval approval activities
• Accountable for delivering \xe2\x80\x9csubmission ready\xe2\x80\x9d 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.
• Apply GxP principles according to the stage of product lifecycle
• 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

Great People want to Work with us! Find out why:Are you interested in working at AZ, apply today!AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .Date Posted 31-May-2024Closing Date 09-Jun-2024AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca