Develop Project Implementation plans and manage regulatory **** items e.g.
mapping, coordination with LRA for regulatory inputsresulting from changes in products, documentation required, timelines for registrations/notifications and phase-in of changes (e.g., ingredients & formulation review, AW / labelling changes and manufacturing / International documentation)
Coordinate preparation of quality & compliant country submission documents to health authorities
Regulatory processes & systems support e.g. GCC, Optiva, regulatory database
Provide weekly update (at a minimum) to region, J&J MRS SMP liaisonagainst KPIs
Prepare management reports slide presentations for management briefings
Immediately raise issues for concern or potential business risks &disruption
Be the local lead for SMP / marketed products regulatory maintenance
Review Regulatory operations work to assure quality, compliance and timeliness of output

一家全球性制药公司，成立于1913年，总部位于英国伦敦，研发总部位于瑞典。卓有成效的处方药产品，包括消化、心血管、肿瘤、中枢神经、麻醉、呼吸和抗感染领域等，其中许多产品居于世界领先地位，产品销售覆盖全球100多个国家和地区。2007年公司全球销售收入为296亿美元。拥有强大的研发能力，2007年研发总投入超过50亿美元。我们在8个国家设有17个研发机构，共有13,000名员工从事与新药研发相关的工作。