Monsanto Regulatory Affairs and Operations Manager, Asia Africa in SINGAPORE, Singapore
Drive the development and implementation of regulatory strategies for securing import, cultivation, and renewal approvals for Monsanto’s biotech products across crops in Asia and Africa; work closely with global, region and country regulatory teams to address regulatory data requirements to ensure quality submission that meet regulatory standards and requirements in Asia and Africa. Provide Operations and Project Management leadership for the operation of the Regulatory Affairs function in Asia Africa and interacting closely with international colleagues in St. Louis to ensure alignment of policies and processes in the Asia Africa Hub countries:
· Lead the submission strategy and dossier preparation for new and existing products within the Asia Africa Region for import, cultivation, and renewal approvals
· Lead coordination of data package strategy with country and global teams and ensure the submission dossiers meet the country data requirements
· Work as liaison between Country RAMs and US RAMs to ensure Asia Africa data requirements are met
· Interact closely with country teams to ensure proper translation of guidelines into regulatory dossiers, assist in developing responses to questions from regulatory authorities, and develop other related documents (e.g., white papers, position statements, etc.) to support submissions
· Establish and maintain regulatory databases for submissions and correspondences
· Responsibility for the RA budgets for the regions and by consultation with the cost center leads. Develop and coordinate the annual budget submission to St Louis. Manage the monthly forecasting process back to St Louis working to ensure forecasting accuracy to +/- 5%. Report deviations and be the main point of contact for US regulatory Operations lead
· Work closely with the Operations Leads from STL to develop, maintain and update the Global Regulatory Databases. To update the databases monthly and communicate with Project Management Lead(s) on status and progress of submissions and approvals via emails and conference calls.
· Keep up to date on all Regulatory operations initiatives, both locally, internationally and globally in order to find operational efficiencies and consistent ways of operating
· Main contact person for ARTT (time tracking system) tracking between country teams and STL, ensure cost centers are updated accurately and provide training (as and when necessary) for ARTT Users.
· Providing operational advice, coordination and training of country Regulatory Affairs Employees.
· Life sciences degree in Plant Breeding, Plant Sciences OR degree in Chemistry, Biology, Genetics or related field.
· Minimum of three or more years of relevant experience in the agricultural, biotechnology, Regulatory/Government/Industry Affairs, pharmaceutical or related scientific based industry
· Demonstrated ability to lead by influence across multiple functions
· Proven ability for multi-tasking with strong project management skills
· Knowledge of Asia Pacific regulatory systems
· Excellent English scientific writing skills
· Ability to interact effectively with a wide diversity of people to meet timelines and local needs
Organization: GLB Regulatory Affairs51177232_
Title: Regulatory Affairs and Operations Manager, Asia Africa
Location: Asia Pacific-Singapore-Singapore
Requisition ID: 01G70
Job: Research & Development
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