CMC RA Reg Manager Submission Excellence and Project Management
Join us at AstraZeneca as a CMC RA Reg Manager Submission Excellence and Project Management! 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 ensure the application of global CMC regulations and guidance within AstraZeneca and lead/contribute to the development of new guidance, policy, and processes. This is your chance to play a part in gaining approval for our novel work on unmet medical needs.
Accountabilities:
As a CMC RA Reg Manager, you will manage the timely preparation and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout their lifecycle. 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. 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 or technical field such as pharmacy, biology, chemistry or biological science with 2+ years of relevant experience
- IT Skills
- Stakeholder & Project management
- Professional capabilities: Regulatory knowledge
Desirable Skills/Experience:
- Masters degree in Science or technical field such as pharmacy, biology, chemistry or biological science.
- Direct Regulatory Affairs CMC experience with submissions for Biologic and biotechnology derived products
- Knowledge of the drug development process and regulatory submissions
- Understanding of current regulatory CMC requirements
- Lean capabilities
At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, 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. We focus on the solutions for niche patient populations, building a more agile and price implementation of clinical trials.
Are you ready to be a part of our globally connected business and to share learnings and best practices with our leading Regulatory specialists? Are you ready to be an agent of change? If yes, apply now!
Date Posted
19-Sep-2024Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.