International CMC Regulatory Affairs Associate Director I

Job Title: International CMC Regulatory Affairs Associate Director I

Global Career Level:E1

Introduction to role

This role leads and manages complex iCMC projects and product ranges across the portfolioto meet the needs of both AstraZeneca and patients. It combines strong project management with tactical regulatory delivery ensuring international CMC submissions are planned coordinated and executed to high standards and agreed timelines. The role partners closely with CMC Product Leads and stakeholders across the organisation to shape and implement innovative risk-based regulatory strategies. It also ensures international CMC regulations and guidance are applied consistently within AstraZeneca while contributing to the development of new internal guidance policy and processes. Ready to influence decisions challenge thinking and turn a rich pipeline into approved medicines

Accountabilities

Lead the timely preparation and delivery of iCMC contributions to regulatory submissions for medicinal products across the lifecycle marketing authorisation applications and post-approval activities.

Project manage complex international CMC regulatory programmes so that activities and documentation meet high quality standards agreed timelines and business needs maintaining compliance with registered dossier content and tracking Health Authority approval status.

Chair and lead iCMC submission management teams securing delivery of submission documentation that is fit for purpose and designed to enable future operational flexibility.

Apply project management expertise adapting plans and approaches to changing situations to secure on-time delivery.

Identify and highlight resource needs for assigned products to enable effective planning and prioritisation.

Apply appropriate GxP principles according to the stage of the product lifecycle.

Take responsibility for assigned change management activities.

Lead or contribute to cross-SET non-drug projects and act as business owner for critical business processes that accelerate submissions support launches manage regulatory information and ensure regulatory compliance.

Use deep understanding of regional regulatory requirements to assure compliance of iCMC submissions.

Apply robust risk management across activities balancing speed with quality and compliance.

Participate in regulatory execution and delivery meetings providing clear updates and insights to the iRT team.

Model continuous improvement by following processes and standards identifying and solving problems and defining and implementing improvements fostering a learning culture across the team.

Conduct all activities in line with AstraZeneca Values the Code of Ethics and relevant Policies and Standards (including SHE) completing required training on time and reporting potential issues of non-compliance.

Essential Skills/Experience

• University Degree or equivalent professional qualification 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.

• Strong understanding of regulatory affairs globally

• Stakeholder & Project management

Desirable Skills/Experience

• Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or complex biologic products

• Understanding of regulations and guidance governing the manufacture of biotechnology products especially monoclonal antibodies

• Lean capability

• Quality Risk Management

• Experience managing resource requirements for pivotal projects

• People Management Experience: Proven ability to lead and manage teams of 35 members fostering collaboration accountability and performance excellence.

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.

AstraZeneca offers the chance to be part of a science-driven Regulatory function that shapes drug development strategy from early research through launch driving innovative data packages influencing regulators on new technologies and using analytics automation and cross-functional collaboration to secure rapid global approvals that bring life-changing medicines to patients while supporting continuous learning original thinking and career-long development through initiatives such as our Regulatory academy.

If this role matches your skills and ambition apply now to help turn bold development strategies into approved medicines for patients worldwide.

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.