Monsanto Regulatory Affairs Manager – Asia Africa Biotech Team in SINGAPORE, Singapore

Monsanto is seeking one highly motivated individual to join Monsanto Asia Africa Biotech Regulatory Affairs Team as Regulatory Affairs Manager based out in Singapore. In this role, you will lead efforts to obtain and maintain Asia Africa import, cultivation, and renewal regulatory approvals for biotechnology-derived products by driving the development and implementation of regulatory strategies, product dossiers, and agency submissions:

-Lead the submission strategy and dossier preparation for new and existing products within the Asia Africa Region for import, cultivation, and renewal approvals

-Provide the leadership and delivery of global regulatory dossiers in Asia Africa for Monsanto's products in collaboration with colleagues in the global Regulatory organization

-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

-Work with Country regulatory teams to assist in developing responses to questions from regulatory authorities, and develop other related documents (e.g., white papers, position statements, etc.) to obtain regulatory approvals in key export countries

-Establish and maintain regulatory databases for submissions and correspondences

Required to have:

-Minimum of a Master’s degree in Molecular Biology, Crop Science, Genetics, Plant Breeding, Plant Pathology, Biochemistry, Protein Chemistry, Toxicology or related scientific discipline

-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

-Ability to organize data and information effectively

-Ability to write clear and convincing documents

-Ability to work with customers to meet timelines and needs

-Effective negotiation and persuasive skills

-Very strong results orientation, resilience and ability to stay calm under pressure

-Excellent written/oral communication and organization skills

Advantageous to have:

-Advanced degree (PhD) in life science discipline is preferred, with relevant experiences in regulatory affairs, agricultural and/or ag biotech industry

-Experience with the regulatory approval process for biotechnology products

-Prior experience leading successful interactions with country regulatory governing bodies/agencies considered a strong plus

-Successful experience delivering on process improvement initiatives

Organization: GLB Regulatory Affairs51177232_

Title: Regulatory Affairs Manager – Asia Africa Biotech Team

Location: Asia Pacific-Singapore-Singapore-Singapore

Requisition ID: 01IWO

Job: Research & Development

Schedule: Full-time

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