AMEA Regulatory Portfolio Lead for Seedcare and Biocontrol

Role purpose

• Ensure product registrations and regulatory management processes are fully compliant to regulatory related code of conducts and guidelines set out by company and authority
• Manage and be accountable for the registration of the responsible CP portfolio of new and existing active ingredients and products. Seedcare and Biopesticide Lead is responsible for all portfolio in the business scope of Seedcare and Biocontrol including 3rd party technology obtained and arranged by global and regional commercial team (“Global deal” and “Regional deal”). Seedcare technology may contain active ingradients from various indications like insecticide, herbicide and/or biostimulant. If the active ingredient (AI) is primarily used for Seedcare, this role takes lead of such AI. Otherwise, this role is responsible mostly for formulations used for Seedcare. Biocontrol includes all biological origin pesticides to control pest, disese and weed, and semiochemical products (pheromon base). To avoid doubt, this role does NOT include technology based on biostimulants, bio-fertilizer and bio-nutrient
• Develop and implement the regulatory strategies for responsible portfolio (active ingredients and products) to meet the Region’s business objectives and make sure future regulatory risks and threats are taken into account.
• Be the primary contact for the respective Global Product Regulatory managers (GPR) and that for regional functions (Project management, Product Safety, CP Development, PT&E, Production & Supply) and country/CU regulatory team, ensuring that the needs and plans for the responsible portfolio are met.
• Provide leadership and fast, high quality, professional regulatory support to CU and country regulatory teams to gain, maintain and defend national registrations and re-registrations
• Take responsibility for the regional input into the RSTs (Regulatory Steering Team).  Provide strategic regulatory input into the relevant regional MPTs, Regional Project team and r-PLT (Regional Portfolio Leadership Team) from regional regulatory perspective, and lead the regulatory management works for product registration of the responsible products
• Help country team to advocate the needs to shape and develop science base regulatory framework to accept our bio-control technology with reasonable data requirement and in reasonable time line. 
• Liaise with Industry association / Government / Regulatory Authorities and Non Government Organisations to ensure appropriate representation of the company position and necessary advocacy work is in place

Accountabilities

• Lead regulatory management of responsible AI, FNE (Formulation New), FEX (Formulation Extension) and LEX (Label extension) of regulatory projects under the scope of Global portfolio registration projects and AMEA regional registration projects in collaboration with other functions (Project manager, Product Safety, Stewardship, Production & Supply)
• Provide fast, high quality and professional regulatory support and advice to country and CU regulatory teams to gain, maintain and defend national registrations and re-registrations for accountable portfolio (active ingredients and products).
• Ensure product registrations are fully compliant to company guideline and pass required governance processes including, but limited to, label check and other expert assessment for DeCo process and Product safety studies.
• Ensure product registrations are fully compliant and meet regulatory rules and requirements in registering countries.
• Ensure that regulatory input is provided into development programs for consistency and fitness for the purpose.
• Work closely with the Regional Commercial, Technical team and CPD Project managers to ensure that registration plans and timelines are set and communicated to stakeholders and that risks and opportunities in achieving registrations are communicated to and accepted by the business. Monitor competitor products in terms of regulatory profile and positioning and make the knowledge available.
• With in-country and CU regulatory teams ensure registrations are achieved according to plan or the plans are revised to reflect any changes in data requirements or the regulatory environment and the revised plans are clearly communicated to the business.
• Develop and maintain high quality relationships with internal and external customers.
• Anticipate any significant regulatory matters impacting upon our ability to obtain and maintain registrations and consult Regional Portfolio team to mitigate the impact and reflect them into business plan.
• Support and collaborate AMEA CP Regulatory Portfolio Leads to build the regional team and its effective operation with global and country/CU regulatory teams.
• Liase closely with Supply Chain Coordination Manager and Supply chain team to manage sustainable product sourcing of accountable portfolio   
• Map out current regulatory framework for biocontrol technology in key AMEA countries and assess gaps, deficiency and challenges to deliver our technology into market. Develop strategy and plan to shape regulatory framework in priority countries with Business sustainability, other functions and relevant industry associations.
• Work closely with CropLife Asia, Africa-Middle East and other industry associations upon necessity, and anticipate regulatory policy changes and take actions to manage potential issues with key internal stakeholders upon necessity.

Critical knowledge

• Science-related Degree and preferably post-graduate qualification (MSc or PhD)
• Detailed knowledge of worldwide product registration requirements and regulatory science issues, and preferably in-depth knowledge in practical registration or product safety or chemistry discipline such as toxicology, ecotoxicology or e-fate etc
• A sound understanding of project management
• Good understanding of Agribusiness and preferably Agrochimicals

Critical experience

• Experience in Product registration or Product Safety, or other relevant product development business area
• Experience in the development of regulatory strategies, regulatory interpretation of technical information, management of technical/regulatory issues preparation of submissions and responses to authorities, understanding of legislative and regulatory environment
• Proven track record in results orientation and project management
• Proven ability to work within and contribute to cross-functional teams
• Proven ability to deal with complex regulatory issues, and develop effective strategies for managing and leading the team

Critical technical, professional and personal capabilities

• Good understanding of the significance of scientific data in the regulatory context.
• Strong communication, influencing and interpersonal skills.
• High degree of strategic thinking with business acumen and technical regulatory competence.
• Analytical thinking
• Strategic thinking
• Result orientation

Critical leadership capabilities

Sets ambitious strategic goals

Uses foresight to develop ambitious strategies, and aligns individual and team objectives with the bigger picture.

Communicates with impact

Gains commitment of individuals and stakeholders in a compelling way.

Focuses on customers

Is dedicated to meeting the expectations and requirements of internal and external customers.

Manages for performance

Skillfully plans, organizes and monitors performance to create value and achieve excellence in delivery.