12 Oct
AstraZeneca
Mississauga
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 Role:
Join us at AstraZeneca as a CMC Regulatory Affairs Manager Submission Excellence and Project Manager. In this role, you will manage all aspects related to the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will contribute and lead the regulatory CMC components of business-related projects.
They will have effective levels of interactive communication with stakeholders 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 guidance, mentorship, policy, and processes.
Accountabilities:
As a CMC RA Manager, you will manage the timely preparation and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout their lifecycle, with emphasis on clinical programs, and also including marketing authorization applications and all post approval activities. You will deliver submission quality CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures.
You will ensure that publishing tools are in place and perform publishing of the CMC sections in a timely manner. You will also develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions. You will give advice, train and mentor other team members. You will train others in procedures and practices relating to Veeva. Additionally, you will be responsible for change management as assigned and conduct activities consistent with Company Values and in compliance with the Code of Ethics.
Essential Skills/Experience:
- Bachelors 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 knowledg
Desirable Skills/Experience:
- Masters 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
- Direct/indirect Regulatory Affairs CMC experience with clinical 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
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 emailing ***************@astrazeneca.com.
#hybrid
Date Posted
11-Oct-2024
Closing Date
24-Oct-2024
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.
▶️ CMC Regulatory Affairs Manager, Submission Excellence & Project Management
🖊️ AstraZeneca
📍 Mississauga