Biological Assessment Dossier (BAD) Specialist

About UPL

UPL is a leader in global food systems and with the acquisition of Arysta LifeScience, is now one of the top 5 agricultural solutions companies worldwide. With revenue of US$5 billion, UPL has presence in 130 countries. With market access to 90 percent of world’s food basket and focused on high-growth regions, UPL represents a compelling value proposition for growers, distributors, suppliers and innovation partners in a consolidating market. UPL offers an integrated portfolio of both patented and post-patent agricultural solutions for various arable and specialty crops, including biological, crop protection, seed treatment and post-harvest solutions covering the entire crop value chain.

Role purpose

Prepare Biological Assessment Dossiers and responses to regulator questions in support of product (re-)registration submissions in accordance with EU Regulation 1107-2009-EC.

To provide robust dossiers to achieve successful registration of products in full compliance with regulations and within budget.

Internal Stakeholders

Reporting to Product Development Manager

In contact with BAD coordinator, Regulatory team, EU marketing managers, country Development Managers

Responsibilities/Accountabilities

• Manage and produce Biological Assessment Dossiers to support the agreed product strategy and European Union and global registration timetables
• Outsource certain BADs to CROs and ensure coordination, monitoring and review of their work before submission
• Answer questions from Regulators within precise deadlines
• Set standards for report and data formats ensuring they comply with EPPO guidelines.
• Assess scientific / biological data for each product within each country and identify data gaps for the production of Biological Assessment Dossiers and notify these requirements to the Efficacy Specialist and appropriate Product Development Manager.
• Identify and interpret changes to the efficacy regulations and recommend strategies to encompass them in day-to-day operations.
• Assist with the management of global data to support the Crop Protection business.
• Contribute to the maintenance of a biological database for efficient data processing in main regulatory formats as described by OECD.
• Collaborate with colleagues from other disciplines and functional groups
• Provide audit and guidance to contract research organizations, which may involve travel.
• Ensure all work is economically justified and manage approved budget ensuring short fallings or under spend are recognized and reported to management.
• Provide regular updates to Project managers
• Be an active member of the group, providing guidance and mentoring to the junior members.

Expected contributions

• Agreed registration plan delivered on time and to specification and within budget

Key competencies required for the role

• Good organization skills and experience of working in multi-disciplinary project teams with the ability to manage simultaneous multiple projects to deadline
• Broad range of experience in biological efficacy testing in laboratory and field situations across all product disciplines.
• Ability to understand, interpret and assess biological data in order to review and write high quality trial reports and BADs
• Good verbal communication skills
• Collaborative and team building skills
• Strong project management skills
• Computer literacy for the use of Excel and ARM, plus other MSOffice software.
• Experience in cataloguing and indexing data
• A sound knowledge of agronomy, crop protection practices and understanding of plant protection products
• Familiarity with quality systems such as Good Laboratory Practice (GLP) & Official Recognition (ORETO)

Qualification

• Strong written and spoken English
• 4-7 years industry or contractor experience
• Masters degree or higher in a Biological discipline

Location

• Europe

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