Job Title: International CMC Regulatory Affairs Manager I

Global Career Level: D

Role Type: Individual Contributor for International Markets

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work.

About the role

Introduction to role

The role holders effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics/biologics) to deliver the needs of both the AZ business and the customer. They project manage international 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 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 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

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, 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 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.

Why AstraZeneca:

AstraZeneca offers the chance to work on meaningful science that directly shapes how life-changing medicines reach patients worldwide, with a rich pipeline that spans the full drug development journey. Regulatory professionals collaborate across locations, therapy areas and external partners to solve complex problems, use data and analytics to shorten development cycles, and pioneer modern regulatory approaches for niche patient populations. It is an inclusive environment where diverse perspectives are valued, people are trusted with real responsibility, encouraged to ask questions, try new ideas and act as agents of change, while benefiting from global opportunities to grow skills, explore different roles and build a long-term career.

Where Can I Find Out More?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Call to Action:

Ready to step up, drive impactful CMC submissions and help bring transformative medicines to patients faster? Apply now.

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 align with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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.