• Provide technical excellence with responsibility for preparing the summaries included in dossiers submitted for review by regulatory authorities (e.g., JMAFF, FSC, etc …) in the Safety Assessment sections of the dossier, include development and peer review.
• Review and critically assess regulatory and/or safety data and provide expert advice and guidance both internally and externally. Feedback constructively on relevant issues and initiate process review as appropriate.
• Work with staff from other groups in the business to ensure the timely preparation of documents within budget for own work and those that are being project led. Escalate budget shortfalls to Management and lead or support engagement with Business Development colleagues and Commercial Management colleagues to address such shortfalls in a timely manner (i.e., before the budget is exceeded to gain client agreement for additional budget).
• Take decisions and make opinions on scientific and regulatory issues, provide strategic comments within sponsored projects and communicate these orally and/ or in writing to the client, in collaboration with peers.
• Organize and manage regulatory documentation, literature/safety data reviews and position papers.
• Attend and contribute to internal (web) meetings and with the Sponsor, as applicable.
• Provide expert consulting and regulatory services to clients in area of expertise, assist with identifying and processing potential sources of new business within projects and ensure these are adequately funded.
• Provide a weekly timesheet for work performed, with enough detail to ensure project tracking is possible, in the Departmental system.
• Prepare timely completion of local attendance and data capture systems, i.e., “Kinnosuke”, or its equivalent, as required.
• Contribute to project planning activities and actively use the Departmental planning system, i.e., WorkFront (or its equivalent) for the purpose of understanding workload and bottlenecks. Support assigned and delegated work plans prepared by the scheduling team representative, to achieve completion of the plan. Escalate any difficulties with the schedule in a timely manner.
• Support other Japan project planning initiatives through collaboration with dedicated staff to create oversight of workload, progress and shortfalls in capacity in all Crop Protection services in Japan.
• Demonstrate the ability to work on various assignments simultaneously, providing “stand-alone” expertise.
• Develop new and support existing client relationships and help acquire revenue-earning opportunities.
• Co-operate with internal personnel, external clients’ and regulatory authorities in order to support documentation and services to the required standard and in a timely fashion.
• Support the recruitment activities for hiring talent into the business.
• Represent Regulatory Consulting during internal and external (i.e., with client) discussions prior to project award (e.g., on capabilities) and after project award (i.e., expectations, timelines, and deliverables).
• Interact with support staff including but not limited to Submissions, Publishing, Project Management, Quality Control, and staff from sales, contracts, and invoicing.
• Represent Regulatory during development and implementation of business processes as required; providing input and follow-up, as appropriate.
• Work within the Regulatory group to mentor colleagues and train the associated staff.
• Highlight and help resolve any issues arising from the Regulatory process. Work proactively to implement process change, working individually or leading a team as appropriate.
• Develop processes and procedure to ensure best working practices are maintained.
• Develop and maintain optimal department processes and implement effective project-specific strategies.
• Represent the Regulatory Consulting Department on any new technologies being researched globally. Have input into feasibility, user requirements, and user acceptance testing, as required.
• Have input into writing and/ or reviewing process documentation from within the Department of Regulatory Consulting.
• Maintain expertise in appropriate scientific disciplines through participation in relevant scientific and regulatory meetings, either domestically or internationally.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

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