CMCD Individual Contributor
Job description:Responsible for renewal activities according to current SOPs and Global Planning for all markets.Coordination with Industrial Affairs for dossier creation.Publishing of dossier with Reg Ops and coordination with GRA Leads for dossier dispatch Creation of any response documents and coordination with all partners for completion Appropriate database management (SHARE, etc.)Annual Reports (US, Brazil, etc.)Variation Tracking with AffiliatesVariation Data Entry (SHARE)Change Control assistance as assigned by manager.Support other activities including administrative documents for all submission types.eCTD Application Forms (MRP,CP, etc.)Develops global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, vaccines and/or consumer health care products) in collaboration with other parts of GRA.Assures effective involvement with change control systems. Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
Posted 16 days ago