12533 ra cmc manager.

Major Accountabilities; 
`~ Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance
~ Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
~ Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
~ Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
~ Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stake holders. Represent department in cross-functional project teams as appropriate.
~ Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
~ Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans

Key Performance Indicators
~Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation.
~No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control.
~Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders
~RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines.
~Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems.
~Maintains collaborative partnerships with stakeholders.

Experience in; 

Operations Management and Execution

Project Management

Collaborating across boundaries

Cross Cultural Experience

Languages; 

Fluent English