CMC Regulatory Affairs Director and Team Manager Submission Excellence & Project Management
Job Title:CMC Regulatory Affairs Director and Team Manager Submission Excellence & Project Management
Location: Mississauga, ON
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:
Join us at AstraZeneca as a Regulatory Affairs Director (Submission Excellence) Line Manager. This strategic leadership role is accountable for leading a team of Regulatory professionals, providing overall direction, and ensuring the delivery of global CMC regulatory submissions for a product/group of products across the product lifecycle. This role is integral to ourbiologics Respiratory and Inflammation portfolio within our BiopharmR&D business area, where you'll play a key part in gaining approval for new products, as well as new indications, post approval variations and maintenance activitiesfor existing products with important andunmet medical needs.
Accountabilities:
As a Regulatory Affairs Director, you will provide overall direction, develop and line manage a group of regulatory CMC experts within the CMC RA organisation. You will be accountable for recruitment, skill-development, coaching, and performance feedback of team members. You will ensure project activities managed within the team are delivered to a high standard, agreed time scales and meet the AZ business requirements, compliance requirements and regulatory authority expectations worldwide. You will also lead cross SET non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities and management of regulatory information and ensure regulatory compliance on behalf of AZ.
Essential Skills/Experience:
Bachelors degree in Science, Regulatory Sciences or Pharmacy.
7 years experience in Regulatory/Drug development (Industry or Health Authority)
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs
Proven leadership and program management experience.
Proven track record of independently manage complex managerial tasks
Proven track record of coaching and delegation capabilities
Ability to think strategically and critically evaluate risks to regulatory activities.
Ability to work strategically within a complex, business critical and high profile development program.
Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership, decision making and excellent oral and written communication skills.
Experience of people management.
Desirable Skills/Experience:
Masters degree or PhD in Science, Regulatory Sciences or Pharmacy.
10years experience in Regulatory/Drug development (Industry or Health Authority)
At AstraZeneca, we are driven by innovation and originality. We work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We see change as an opportunity, embracing the possibility to learn, grow and evolve. We are striving for technology adoption and automation to drive efficiencies and new innovations. Here we have the ability and autonomy to be an agent of change.
Ready to make a difference? Apply now and join us in our mission to bring hope and solutions to patients across the globe!
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 emailingAZCHumanResources@astrazeneca.com.
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 authorization and employment eligibility verification requirements.
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