Description
Role purpose
Provide regulatory expertise to the Eat Africa BA (EA BA)
Plan and execute regulatory activities for the EA BA. Achieve, extend and maintain the licence to sell (registrations) for Syngenta products
Find innovative registration approaches within the legal regulatory frameworks in the BA
Accountabilities
Provide regulatory expertise to the EABA (including fitness and suitability checks for new projects in the context of local reg. requirements); find innovative registration approaches within the legal regulatory frameworks;
Manage all registration activities for the EA BA: including preparation of registration submissions according to national requirements of PCPB & KEPHIS; answering specific follow-up questions from authorities; covering regulatory aspects of the product label, promotional pamphlets and posters creation process; keeping the Syngenta internal registration database up to date. Cover regulatory aspects of formulation and product site/source changes.
Provide annual plans and timelines for new registrations and re-registration activities on-time and in-line with AME/BA strategy and priorities. Track, periodically review and report registration progress against targets. Keep the BA and AME regulatory team informed on regulatory activities and emerging issues which require proactive management.
Proactively monitor and regularly update both the BA and BU on Freedom to Operate threats (ai reviews, changes in regulations), define FTO action plans and lead and coordinate related regulatory advocacy activities.
Establish and run a network with officials (regulatory authorities) and represent company interests; maintain close contact with local partners to grow and maintain expertise in national registration processes and legislations.
Represent Syngenta in the local industry associations (AAK in Kenya), actively participate and regularly report on any topic relevant to the company.
Ensure, in coordination with and support from the technical lead registration, that trial protocols are developed on time, registration trials are set up and followed continuously for assessment and report writing;
Proactively manage or carry out product-related issues,
Support BA Customer Service/Order Management on regulatory matters (shelf-life extensions, country of origin issues, review of inspection certificates, etc.);
Ensure cross-functional cooperation with the BA East Africa team and especially with the local technical teams (KE, UG, TZ) and AME Regulatory team.
Qualifications
Knowledge, experience & capabilities
Degree in Science/Agriculture or relevant technical qualification;
Good knowledge of regulatory requirements and trends in Kenya, Uganda and Tanzania;
Good knowledge of EU registration and general registration requirements. Good level of knowledge of the general processes and methodology in registration;
Understands development cycles for CP and Seeds.
Experience
Experience in regulatory affairs – gained through 2 or more-year direct experiences in a regulatory role; or through significant technical experience gained in the BA;
Demonstrated strengths in communication, self-organization and problem solving;
Developed negotiation/influencing skills across different cultures
Good level of business understanding & competence
Technical, Professional And Personal Capabilities
Excellent team working, project management and interpersonal skills;
Degree of regulatory experience as a basis for a degree of autonomy from management supervision from AME HQ Regulatory;
Feel for the right moment to consult & update the manager on key decisions and issues;
attention to detail and ability to complete and deliver tasks on time;
Analytical and conceptual thinking with planning and implementation ability;
Good communication in English and local language if needed
Leadership Capabilities
Strong leadership capabilities
Structured mind,
Creative and growth mindset
Transparency in communication
Collaborative mindset (teamwork)
Effective and efficient communication with key stakeholders.
Ability to develop new ideas and challenge existing concepts; strength in planning and time management and excellent organisational skills.
Success Factors & Key Challenges
Acquire a good knowledge of the registration requirements in AME territory in general and in Kenya in particular
Get acquainted with processes and tasks in AME regulatory;
Acquire regulatory know-how and knowledge on watch-outs of a.i.s and products;
Show ability to work accurately and to deliver dossiers/special tasks on time and up to Syngenta standards;
Ensure the best freedom to operate (advocacy and license to sell (registrations) in countries).
Apply via :
syngenta.taleo.net
