* Authoring high-quality CMC documentation for US/ EU / UK countries, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
* Preparing CMC response to health authority questions during development, registration and product lifecycle.
* Actively participating as a member of the global Regulatory CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
* Identifying the required documentation for global submission and negotiate the delivery of approved technical source documents in accordance with project timelines.
* Identifying content, quality and/or timeliness issues with source management, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
* Handling of Change control & its assessment in tools like Veeva, Trackwise, etc
* Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
* Assume activities in working with client tools and coordination/collection/archive of source documentation needed for direct submission to HAs, other database entry activities (Specialized department functions).
* For deliverables in scope, supporting responses to inquiries from clients in response to inspection activities and may provide support during regulatory agency questions
* Coordinating with team when there is a regional, global or therapeutic area impact across multiple countries
* Ability to run training and awareness sessions on CMC writing processes and ability to clearly articulate expectations of the CMC writing process to stakeholders
* Meeting defined targets on productivity, quality and compliance, as set by and overseen by management
* Meeting strategic targets for CMC deliverables as defined for the function, and communicates progress against these targets or issues which affect these targets, and proposes remediation
* Managing the day-to-day activities of direct reports, including project assignments and scheduling. Mentor and train junior staff and other members of the team
