Regulatory Portfolio Lead Biostimulant AMEA & JANZ

Role purpose

• Ensure product registrations and regulatory management processes are fully compliant to regulatory related code of conducts and guidelines set out by the company and the authorities. Manage and be accountable for the registration of the responsible Biostimulant portfolio of new and existing products.
• Biostimulant Lead is responsible for all portfolio in the business scope of Biostimulants including 3rd party technologies obtained and arranged by the global and regional commercial team (Global deal and Regional deal). This role includes technologies based on Biostimulants but also Nutrient use efficiency products.
• Develop and implement the regulatory strategies for the responsible portfolio to meet the 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 teams ensuring that the needs and plans for the responsible portfolio are met.
• Provide leadership and fast high quality professional regulatory support to country/CU regulatory teams to gain maintain and defend national registrations and re-registrations.
• 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/CU to advocate the needs to shape and develop science base regulatory framework to accept our Biostimulant 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 portfolio such as FNE (Formulation New) FEX (Formulation Extension) LEX (Label extension) and re-registration of regulatory projects under the scope of Global portfolio registration projects and AMEA regional registration projects in collaboration with other functions (Product manager Project manager Product Safety Stewardship Production & Supply)
• Provide fast high quality and professional regulatory support and advice to country/CU regulatory teams to gain maintain and defend national registrations and re-registrations for accountable portfolio.
• Ensure product registrations are fully compliant with company guidelines and pass all required governance processes including but not limited to label checks 3rd-party governance and other expert assessments (for DeCo 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 r-PLT to ensure that registration plans and timelines are established and communicated to stakeholders and that risks and opportunities related to registration achievements are communicated to and accepted by the business. Monitor competitor products regulatory profiles and positioning and provide the necessary information to relevant teams.
• Ensure that in country/CU regulatory registrations are achieved according to plan or that plans are revised to reflect any changes in data requirements or the regulatory environment and that such revisions are clearly communicated to the business.
• Develop and maintain high quality relationships with internal and external stakeholders.
• 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 with other Regional 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 Biologicals in the AMEA countries and assess gaps deficiency and challenges to deliver our technologies into the market. Develop strategy and plan to shape regulatory framework in the high-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.

Qualifications :

Critical knowledge

• Science-related Degree and preferably post-graduate qualification (MSc or PhD)
• Detailed knowledge of global product registration requirements especially in biostimulants fertilizers and biocontrol regulations. Preferably in-depth knowledge in practical aspects of registration product safety or a chemistry discipline such as toxicology ecotoxicology or environmental fate.
• Sound understanding of project management
• Strong understanding of agribusiness and preferably agrochemicals

Critical experience

• Experience in product registration product safety or other relevant product development fields
• Experience in developing regulatory strategies; interpreting technical information from a regulatory perspective; managing technical and regulatory issues; preparing submissions and responses to authorities; and understanding the legislative and regulatory environment
• Proven track record of delivering results and managing projects
• Proven ability to work within and contribute to cross-functional teams
• Proven ability to address complex regulatory issues and develop effective strategies for managing and leading teams

Critical technical professional and personal competencies

• Strong understanding of the significance of scientific data within a regulatory context
• Strong communication influencing and interpersonal skills
• Strong strategic thinking combined with business acumen and technical regulatory expertise
• Excellent leadership skills
• Analytical thinking and strategic thinking
• Proactive in identifying issues and developing and implementing creative strategies for addressing them
• Able to structure and simplify complex data and information and provide clear and simple messages for non-experts
• Highly-developed interpersonal skills
• Able to manage change and to hold ambiguities

Additional Information :

Additional information

• Will be required to travel occasionally within AMEAJANZ and elsewhere
• Will need to be able to communicate effectively with colleagues in virtual condition
• Will need to be able to influence and lead staff without having direct line management responsibility
• Will need to attend meetings of industry associations and external stakeholders to manage regulatory matters

Remote Work :

No

Employment Type :

Full-time