Job Description

Job Title: CMC RA Manager I Submission Excellence & Project ManagementCareer Level - DIntroduction to role:
Join our Biopharmaceuticals R&D team as a CMC RA Manager I Submission Excellence & Project Management. This role is pivotal in managing the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges, ensuring the needs of both AstraZeneca and our customers are met. You will project manage global CMC regulatory submissions and contribute to the regulatory CMC components of business-related projects. This is your chance to take ownership and be recognised as a leader across the business.Accountabilities:
The role holders project manage all aspects related to the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics/biologics/devices) to deliver the needs of both the AZ business and the customer, including publishing of clinical and marketing regulatory documents. They project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle including pre and post approval activities. 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, policy, and processes.Essential Skills/Experience:
- University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
- Minimum 8 years of relevant experience from biopharmaceutical industry.
- Breadth of knowledge of manufacturing, project, technical and regulatory management.
- IT Skills.
- Stakeholder & Project management.
- Professional capabilities: Regulatory knowledge.Desirable Skills
- Knowledge of the drug development process and regulatory submissions.
- Understanding of current regulatory CMC requirements.
- Direct/indirect Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products.
- Understanding of regulations and guidance governing the manufacture of biotechnology products.
- Lean capabilities.When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That\'s why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean we\'re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.At AstraZeneca, we are committed to turning our drug development strategies into reality. We think broadly about patients and what it takes to prevent and treat diseases. We are proactively involved in the strategy, changing the course for approvals and influencing regulators on new technology. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. We are part of the solution, involved in key discussions, acting as both a drug developer and Regulator. We constructively challenge each other to think of the best approach and influence external Regulators. We are striving for technology adoption and automation to drive efficiencies and new innovations.Are you ready to step up and showcase what Regulatory can do around the business? Apply now!Date Posted 29-Jul-2024Closing Date 09-Aug-2024AstraZeneca 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.

AstraZeneca