AstraZeneca looking for CMC Regulatory Affairs Associate Director

AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.

Post : CMC Regulatory Affairs Associate Director I

Job Description
About Role
The role holders effectively manage projects or complex product ranges across the portfolio throughout the product lifecycle to deliver the needs of both the AZ business and the customer and will demonstrate strong project management and tactical delivery expertise. They will be accountable for interfaces with CMC Product leads, proactively partner with stakeholders across AZ organisation to help deliver and implement innovative risk based regulatory strategies. They project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards and timelines. The role holder will drive the delivery of the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with stakeholders and project team members including CMC Regulatory Managers directly advising and influencing those.

Job Responsibilities
• Manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle, including clinical programs, marketing authorisation applications and all post approval activities
• Project manage complex global CMC regulatory programs ensuring that project activities and documentation are delivered to the required high standard, agreed timelines, and meet the business requirements, compliance with the registered dossier content through maintenance and communication of Health Authority approval status.
• Lead CMC submission management teams. Ensure the delivery of submission documentation which is fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.
• Apply project management expertise with the ability to adapt to changing situations to ensure timely delivery.
• Highlight resource needs for product as appropriate for effective planning purposes.
• Apply GxP principles according to the stage of product lifecycle
• Responsibility for change management as assigned.
• Lead /contribute to cross SET non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities / management of regulatory information and ensure regulatory compliance on behalf of AZ.
• Has expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
• Applies an appropriate level of risk management across activities.
• Participation in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team.
• AstraZeneca drives business performance through continuous improvement, we therefore expect all employees to:
• Follow processes and work to standards,
• Identify and solve problems
• Define and implement improvements.
• Leaders will lead by example in creating a learning & continuous improvement culture.

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:
• Follow processes and work to standards, Identify and solve problems . Define and implement improvements.

Candidate Profile
Essential
• University Degree or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science.
• Minimum 11 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
• 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.

Additional Information
Experience : 5+ years
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 10th August, 2023