Role - CMC Regulatory Manager

Duration - 12 months Location - Remote, UK IR35 Status - Outside

The role holders project manage all aspects related to 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, 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. 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.

Job Responsibilities

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:

• Manage the timely preparation (may include authoring) 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 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.
• Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.
• Leads/represents PT&D and Pharm Sci on cross-functional work streams
• 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.
• Proactively share learning from own projects with other colleagues
• Where applicable, act as Subject Matter Expert (SME) or Sub-Process Owner (SPO) contributing to and advising project teams.
• Gives advice, trains and mentors other team members.
• Trains others in procedures and practices relating to ANGEL within PT&D and Pharm Sci
• Raise change requests (ANGEL), manage, escalate & input into the cross functional vote.
• 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