Job Description

Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA\'s on REG CMC questions to support new product or post marketed launches.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.
• 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.
• 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; 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.

Minimum Requirements:
Work Experience:

• Cross Cultural Experience.
• Operations Management and Execution.
• Collaborating across boundaries.
• Project Management.

Skills:

• Change Control.
• Cross-Functional Teams.
• Documentation Management.
• Negotiation Skills.
• Project Management.
• Regulatory Compliance.
• Risk Assessment.
• Risk Management.

Languages :

• English.

Skills Desired Change Controls, Cross-Functional Teamwork, Document Management, Negotiation, Project Management, Regulatory Compliance, Risk Assessments, Risk Management

Novartis