Functions as CMC Strategist for Life Cycle Management (LCM), working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. Able to drive the regulatory submissions with minimal guidance.
Responsible for the preparation and finalization of Global Regulatory Strategy, CTD sections of supplements / variations for LCM submissions, Annual Reports and ensures effective data presentation and quality.
Responsible for effective coordination with the cross functional teams, site and Global RA teams for the review and finalization of supplements to ensure effective data presentation and quality.
Responsible for effective review and providing timely feedback to the teams on technical documents including batch documents related to submission (batch records, Exhibit batch and stability protocol).
Provides regulatory assessment and supports Change Control Assessment.
Ensures commitments (module 2-5) made to health authorities are entered into tracking systems and are tracked to closure, as appropriate.
Provide regulatory support for the assigned products/ projects, participates and provides inputs in technical reviews and strategic discussions on LCM submissions and Change Control reviews as assigned.
Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, team lead and core team.
Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.
Responsible for ensuring compliance to Companys submission standards, policies and procedures.