International CMC Regulatory Affairs Manager II

Introduction to role:

Are you ready to turn breakthrough science into approved medicines faster Do you thrive at the intersection of CMC excellence regulatory strategy and real-world impact for patients with few options

In this role you will effectively manage the production of Chemistry Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs of both the AZ business and the customer. You will project manage international CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. You will contribute and lead the regulatory CMC components of business-related projects. You will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated. You will ensure the application of international CMC regulations and guidance within AstraZeneca and lead/contribute to development of new guidance policy and processes.

Accountabilities:

• Manage the timely preparation (include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout marketing authorisation applications and all post approval approval activities

• Accountable for delivering submission ready CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.

• Documenting maintenance and communication of Health Authority approval status.

• Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.

• Project management expertise with the ability to adapt to changing situations to ensure on time delivery.

• Ensure the learning from own projects are shared with other colleagues/within the functions.

• Supporting the agreed strategy to employ fit for purpose content applying regulatory intelligence and to optimise proposed submission content

• Participation in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team.

• Contribute to business process optimisation activities to reduce waste and ensure efficiency.

• Continually evolve and develop the regulatory expertise through proactive recording and communications of Health Authority interactions responses and commitments.

• Apply GxP principles according to the stage of product lifecycle

• Responsibility for change management as assigned.

• Understands application of appropriate risk management across own activities.

• Demonstrate research skills in understanding regulations and guidance from different regulatory agencies

Typical Accountabilities (per AZ framework and regulatory expectations):

• 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.

• AstraZeneca drives business performance through continuous improvement we therefore expect all employees to: 1) Follow processes and work to standards 2) Identify and solve problems 3) Define and implement improvements.

Essential Skills/Experience:

• University degree in a science or technical field such as pharmacy biology chemistry or biological science.

• Minimum 10 years of Relevant experience from biopharmaceutical industry or other relevant experience

• Breadth of knowledge of manufacturing project technical and regulatory management.

• IT Skills

• Stakeholder & Project management

• Professional capabilities: Regulatory knowledge

Desirable Skills/Experience:

• Knowledge of the drug development process and regulatory submissions

• Understanding of current regulatory CMC requirements

• Direct/indirect Regulatory Affairs CMC experience with submissions for medicinal products

• Understanding of regulations and guidance governing the manufacture of medicinal products

• Lean capabilities

When we put unexpected teams in the same room we unleash bold thinking with the power to

inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here your CMC regulatory expertise unlocks the full potential of pioneering therapies for patients with urgent needs. You will work with diverse specialistsscientists engineers quality leaders data and regulatory expertswho come together to solve complex problems and secure rapid global approvals. We value kindness alongside ambition and empower you to ask bold questions adopt modern tools and share knowledge across a globally connected network. With a rich pipeline and exposure to the full product lifecycle you will grow your impact while helping transform breakthrough science into approved medicines that reach people faster.

Call to Action:

Step into this role to accelerate global approvals and grow your impactbring your CMC regulatory leadership to where it will matter most today!

Date Posted

Closing Date

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.