CMC Regulatory Affairs Director

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.

Introduction to role

The CMC Regulatory Affairs Director will provide strategic, operational, and tactical expertise for projects and complex product ranges from development through to global launch and post-approval lifecycle management. Representing CMC in various networks across the business, including Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Global Supply Teams, and Global Quality and Operations, the role holder will also lead the development of new guidance, policy, and processes. As a key partner for identified customer functions, the role holder will facilitate high-quality partnerships both within and external to AstraZeneca. Support and mentor CMCRA teams on products/projects and specialist areas, using expertise in dossier submissions and project management.

Accountabilities

• Provide CMC RA expertise across business functions and potentially lead key business improvement initiatives.
• Offer operational, tactical, and strategic CMC RA expertise for CMC submissions throughout a product's lifecycle.
• Lead CMC-related interactions with Health Authorities globally when necessary.
• Provide expert regulatory strategic guidance in support of operational initiatives, including complex/accelerated projects and post-approval changes.
• Contribute to or lead policy setting and strategy development in the CMC RA environment.
• Lead knowledge sharing and provide coaching within CMC RA and broader business functions.
• Manage high-level risk by making complex judgments and developing innovative solutions, including proactive risk management and mitigation.
• Offer clear and concise mentorship on current CMC regulatory requirements to assist with business planning.
• Support the implementation of agile and novel approaches in CMC Dossier Management to enhance flexibility and efficiency.
• Participate in or lead due diligence teams as necessary.
• Lead or contribute to cross SET non-drug projects and act as a business owner for business processes to ensure accelerated submissions, support launch activities, manage regulatory information, and ensure regulatory compliance.
• Conduct activities consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role.

Essential Skills/Experience

• Bachelor's degree in Science, Regulatory Sciences, or Pharmacy.
• 7 years of experience in Regulatory/Drug development (Industry or Health Authority).
• Breadth of knowledge of manufacturing, project, technical, and regulatory project management.
• Strong understanding of regulatory affairs globally.
• Direct Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology-derived products.
• Stakeholder & Project management.
• Professional capabilities: Regulatory knowledge.

Desirable Skills/Experience

• Master's degree or PhD in Science, Regulatory Sciences, or Pharmacy.
• 10 years of experience in Regulatory/Drug development (Industry or Health Authority).
• Business, financial, and supply chain understanding/awareness.
• Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies.
• Experience with regulatory health authority interactions, inspections, and/or external advocacy/regulatory policy.

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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 AZCHumanResources@astrazeneca.com.

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