CP Regulatory Biologist

ACCOUNTABILITIES

Overall Business Accountabilities

Interface between internal stakeholders & CRO’S

• To prepare Residue trials list based on decisions taken for products to be submitted during portfolio and pipeline meetings where cross functionally agreement reached,
• To review database to find out necessary studies and information’s (PHI, dose rate etc.) which are relevant to residue trials to be in the scope and follow up MRL’s sets in EU,
• To create network and communicate with CRO’s on the purpose and identify the eligible/s to be worked with,
• To make sure that the draft agreements to be signed off are approved by necessary functions and aligned with internal policies
• To sign agreements with CRO’S on conducting residue trials,
• To follow all residue trials up with CRO’S and ensure the trials are set on time and being conducted according to requirements mentioned in local official guidelines,
• To conduct residue trials and write residue report where necessary,
• To ensure samples are taken by CRO’s and send to Lab on time where residue analysis is done,
• To follow up residue analysis at Lab and ensure analysis report to be sent,
• To review and approve both residue trial and analysis reports received from CRO’s or Lab before submission,
• Involves in project scoping / peer-reviewing for local submissions,
• Remain up to date with latest regulatory developments and ensure current requirements are followed in product submissions,
• Responsible for local GAP setting (Good Agricultural Practice) together with Regulatory Manager

Interface between the national authorities and internal stakeholders

• To follow up and respond for clarification required on residue trials and lab analysis by registration committee,
• Engages in local resistance monitoring and strategy and participates in relevant local working groups [Marketing, Technical &CPD teams)]
• Serves and Liaises with local regulatory authorities as company representative activities (institutes / associations/ universities),
• Writes National Addenda according to national requirements and based on data by Product Biology or local external stakeholders.

As a world market leader in crop protection, we help farmers to counter these threats and ensure enough safe, nutritious, affordable food for all – while minimizing the use of land and other agricultural inputs. Syngenta Crop Protection keeps plants safe from planting to harvesting.  From the moment a seed is planted through to harvest, crops need to be protected from weeds, insects and diseases as well as droughts and floods, heat and cold. Syngenta Crop Protection is headquartered in Switzerland.

KNOWLEDGE, EXPERIENCE & CAPABILITIES

Critical knowledge

• Graduated from Plant Protection Department at Faculty of Agriculture and have Certificate for conducting Bio efficacy and Residue trials (preferably phytopathology)
• Excellent networking capabilities
• Able to teamwork in multinational environment
• Strong technical communication
• Strong verbal and written English

Critical experience

• Experience in conducting Residue trials and reporting,
• Have knowledge on Directive on Trials and ability to adopt the change/s in Directive,
• Experience in the implementation, management and analysis of Residue or biological field trials
• Experience in managing development projects,
• Knowledge of the technical properties of Syngenta and competitor products and associated technologies
• Good understanding of technical and preferably also of regulatory aspects.