CMC Regulatory Affairs Manager

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

As a CMC RA Regulatory Manager for Submission Excellence and Project Management, you will ensure the timely preparation and delivery of CMC contributions to regulatory submissions, including clinical programs and marketing authorization applications for designated product ranges. This includes managing global CMC regulatory submissions to ensure project activities and documentation meet required standards. You will coordinate the regulatory CMC aspects of business-related projects, ensuring effective communication with collaborators and project team members to meet deadlines and regulatory requirements. Additionally, you will apply global CMC regulations and guidance within AstraZeneca and contribute to the development of new guidance, policy, and processes.

Accountabilities

• Manage the timely preparation (may include authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout the lifecycle; including clinical programs, marketing authorization applications, and all post-approval activities.
• Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality.
• Lead/represent CMC RA on cross-functional work streams.
• Document maintenance and communication of Health Authority approval status.
• Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions.
• Adapt to changing situations to ensure on-time delivery through project management expertise.
• Proactively share learning from own projects with other colleagues.
• Act as Subject Matter Expert (SME) or Sub-Process Owner (SPO) contributing to and advising project teams where applicable.
• Provide advice, training, and mentorship to other team members.
• Train others in procedures and practices relating to CMC RA activities.
• Support the agreed strategy to employ fit-for-purpose content applying regulatory intelligence to optimize proposed submission content.
• Participate in regulatory execution and delivery meetings, providing relevant updates to the CMC team.
• Contribute to business process optimization activities to reduce waste and ensure efficiency.
• Continually evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses, and commitments.
• Apply GxP principles according to the stage of the product lifecycle.
• Responsible for change management as assigned.
• Understand the application of appropriate risk management across own activities.
• Demonstrate research skills in understanding regulations and guidance from different regulatory agencies.
• Conduct activities and interactions consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
• Follow processes and work to standards, identify and solve problems, define and implement improvements.

Essential Skills/Experience

• Bachelor’s 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 knowledge.

Desirable Skills/Experience

• Master’s 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 and regulatory submissions with a particular emphasis on early clinical development
• Experience working with Veeva Enterprise Regulatory Vault (ERV) Direct/indirect Regulatory Affairs CMC experience with submissions for biologics and biotechnology-derived products such as monoclonal antibodies or complex 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:

• GTAA Top Employer Award for 11 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

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.

#LI-Hybrid

AstraZeneca 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 authorisation and employment eligibility verification requirements.