RA Reg CMC Assoc Director

Major accountabilities:

• Formulate, lead and drive global CMC regulatory strategy drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance.
• Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions.
• Identify the required documentation and any content, quality and/or timeliness 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 Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and guidelines.
• Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders.
• Lead, prepare and communicate CMC Risk Management Assessments, contingency plans and lessons learned on major submissions and escalate as appropriate.
• Initiate and lead Health Authority interactions and negotiations; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
• Provide strategic advice and direction within the department and cross-functionally through specialized assignments.
• Share regulatory knowledge with less experienced members of RA CMC department.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Produces high quality strategic project documentation and presentations; adapts strategies to anticipate evolving project needs.
• 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 and builds commitment.
• RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines.
• Plans ahead considering emerging trends.
• 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.

Minimum Requirements:
Work Experience:

• Managing Crises.
• Cross Cultural Experience.
• Critical Negotiations.
• Functional Breadth.
• Project Management.
• Operations Management and Execution.
• Collaborating across boundaries.

Skills:

• Change Control.
• Drug Development.
• Lifesciences.
• Negotiation Skills.
• Pharmaceutical Products.
• Product Lifecycle Management (Plm).
• Project Management.
• Regulatory Compliance.
• Risk Management.

Languages :

• English.