Regional Regulatory Trait Manager
The position has responsibility to manage regulatory data strategies to secure import, cultivation, and renewal approvals for Bayer's biotech products across crops in APAC countries; manage new biotech products and associated technologies in APAC region, address regulatory data requirements to ensure quality submissions that meet regulatory standards and requirements in APAC.
YOUR TASKS AND RESPONSIBILITIES:
Develop dossier preparation and submission plans for new and existing products within the APAC region for import, cultivation, and renewal approvals
Introduce and manage new biotech products and associated technologies in APAC region
Development of data strategy in APAC, and coordinate with country and global teams to ensure quality dossier submissions that meet regulatory requirements
Work as liaison between Country and global regulatory teams to ensure APAC data requirements are met
Interact closely with country teams to ensure proper translation of biotech 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 obtain regulatory approvals in the region
Identify opportunities to improve biotech dossier quality and efficient dossier development process
Develop and manage regulatory plans for submissions and correspondences in APAC
WHO YOU ARE:
Education: BS or MS in biochemistry, molecular biology, plant biology, protein chemistry, agronomy, plant breeding, chemistry or related discipline.
Experience: Minimum of 4 years or more of regulatory affairs or relevant experiences in agricultural, biotechnology, pharmaceutical or related industry.
Proven ability for multi-tasking with strong project management skills.
Ability to organize data and information effectively.
Ability to work with customers to meet timelines and needs.
Strong results orientation, resilience and ability to stay calm under pressure
Highly developed written/verbal communication and organization skills.
Application Period: 12/10/2021 - 12/20/2021 Reference Code: 548701
Division: Crop Science Location: Singapore
Functional Area: Regulatory Affairs Position Grade: VS 1.2
Employment Type: Regular Work Time: 40 hours
Bayer (South East Asia) Pte Ltd
2 Tanjong Katong Rd