Manager,Regulatory Affairs

Job Field: Research & Development
Location: Minato, JP
Company: BASF Asia Pacific
Job Type: Experienced
Job ID: EN_JP_25223

We are the world's leading chemical company because we offer intelligent solutions for our customers and for a sustainable future. We have over 110,000 employees connecting around the world. For you, this means an almost unlimited range of job opportunities, career development and lots of potential to continue learning . At BASF we believe strongly in the power of connected minds.

Description

BASF started doing business in Japan in 1888. Activities cover four business segments including chemicals, performance products, functional materials & solutions and agricultural solutions. BASF maintains a strong research and development presence in Japan including the Yokohama Innovation Center (engineering plastics) and the Research and Development Laboratory and Application Technology Center for Battery Materials in Amagasaki. Objectives of the Position

Why does this position exist? With what permanent objectives? Replacement of departing regulatory affairs manager. Responsible for Regulatory Affairs as well as Regulatory Compliance oversight of BASF Plant Science’s biotechnology products in Japan, including future submissions. Main Areas of Responsibilities and Key Activities

(Heading 1): Regulatory Affairs Management for the RBP biotechnology products in Japan 1. Drives the regulatory process in Japan for RBP products, interacting and coordinating with Government Regulators and other RBP functional units to gain regulatory approvals. 2. Responsible for writing and managing high quality regulatory submissions for RBP products by identifying and managing issues that would affect deregulation, responding to questions and requests from Regulatory Authorities, and managing submission and resolution of regulatory challenges. (This is the most important for this position) 3. Responsible for coordinating and managing 4in-country safety study execution and agronomic/ecological evaluations, respectively, to ensure agreement on study design, details, quality expectations and delivery timelines. (This is important for this position) (Heading 2): Ensure regulatory compliance of RBP products in Japan 1. Ensure full compliance with regulatory conditions for conducting field trials and monitoring of field sites in Japan 2. Support RBP Stewardship activities with regard to field trials in Japan, including ensuring documentation and inspections of field locations as requested. 3. (Heading 3): Represent BASF to authorities, associations and other institutions in discussions about RBP products and interests. 1. Represent BASF in various professional settings, and communicate back to RBP about recent developments and trends in the country. 2. Provide leadership as appropriate in local industry associations, including CropLife. 3. Build relationships to communicate effectively with regulatory authorities to ensure successful submissions for deregulation.

Job Requirements (minimum requirement to carry out the work)

Education

• Doctorate degree in molecular biology, plant biology, agronomy, or food science and nutrition, protein chemistry, etc.

Working Experience

• More than 5 years of professional experience in Plant Biotechnology Regulatory Affairs / Regulatory Compliance

Technical & Professional Knowledge

• Must be knowledgeable and have working experience with the Japanese regulations and policies covering the use of biotechnology crops to ensure that the BPS products meet the regulatory requirements
• Demonstrated ability to effectively interact with the Japanese Regulatory Authorities
• Familiar with the Regulatory Science data requirements to support approvals for biotechnology crops in Japan
• Strong intercultural orientation and interest in a multicultural environment
• Excellent English in writing and speaking

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