Provide and ensure timely preparation of high quality CMC regulatory documentation and support in line with global regulatory submission plans and strategies.
1.Preparation and submission of eCTD baseline packages. Transition of all MRP / DCP applications and National Procedures to eCTD according to eCTD roadmap.
Co-ordination within MRC team and global teams for eCTD conversions from a Global perspective. Define and roll-out adapted processes including trainings within department.
2.Accountable for all eCTD conversion, verification and dispatch of submission dossiers to pub-lished team for global and local national eCTD, MRP / DCPs and maintenance submissions under no supervision.
3.Co-ordinate with RCCs and Country Organizations. Provide solutions for local product applications. 4.Setup and train processes and systems, setup pilots and prepare baselines according to EU and national requirements.
Comply to roll-out schedule. 5.Works in MRC team for eCTD preparation, quality review, and timely dispatch of drug dossiers.
6.Provides strategic and operational expertise to MRC team for routine or maintenance submissions to ensure the timely, quality preparation and execution for eCTD conversions.
7.Ensure adherence to internal standards and processes, as well as HA requirements. 8.Reports and updates department head on eCTD conversion progress.
Identify issues and solutions relating to timing, quality and resources. 9.New submissions in Most of World (MoW) regions and its planning as per targets.
10.Life cycle management of approved (MAs) of Complex Products 11.On board, on-job training and grooming of new associates within team 12.
Review of regulatory applications and variation packages prepared by associates 13.Actively participate as a member of the global RegCMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
14.Act as a SPOC for global regions and for specific projects. 15.Organize & Author high-quality CMC documentation (dossiers) for HA submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-
publishing requirements throughout project lifecycle. 16.Prepare CMC responses to health authority questions during development, registration and prod-
uct lifecycle. 17.Identify content, quality and / or timeliness issues with source documents, or any other potential au-thoring issues that may impact submission quality or timelines.
18.Assume activities in support of the global regulatory databases
Key Performance Indicator
CMC / Technical Expert in eCTD compilation for all regulatory regions, is an individual contributor role with responsibility for global regulatory submissions. No direct reports
Post Graduate in Pharmacy or Science (e.g. Organic Chemistry, Analytical chemistry) or equivalent Additional courses in Drug Product Regulatory Affairs would be added advantage Fluency in English required (oral and written) Minimum 10+ years of experience in RegCMC area