Role purpose
Provide regulatory expertise on SYT active substances relevant for EASA business area.
Elaborate the BA registration strategy with the objective to support the BA 5-year sales plan (FTO management).
Find innovative registration approaches within the legal regulatory frameworks in the EASA countries and steer the regulatory team in the BA.
Plan and coordinate regulatory activities EA and SABA and support the REG Team for insecticide and Seedcare portfolio management.
Dimensions
Financial: Budget: 40 m $ (EASA)
People: No of direct reports: 4, No of indirect reports: 0
Geographic Scope: East and Southern Africa
Accountabilities
Provide regulatory expertise to set-up a tailor-made FTO strategy jointly with others key functions, to protect Syngenta FTO (including fitness and suitability checks for new projects in the context of local reg. requirements); find innovative registration approaches within the legal regulatory frameworks.
Provide annual plans and timelines for new registrations and re-registration activities on-time and in-line with the strategy and priorities for the BA; track, periodically review and report registration progress against targets; work closely with the Regional (Asia Middle East and Africa) Regulatory Portfolio Indication Leads to update them on the portfolio management.
Proactively monitor and regularly update both the BA and CU on Freedom to Operate threats (ai reviews, changes in regulations) the whole BA portfolio, define FTO action plans and lead and coordinate related regulatory advocacy activities the BA.
Support his team in establishing and running a network with officials (regulatory authorities) in EASA and represent company interests; maintain close contact to local partners in order to grow and maintain expertise of national registration processes and legislations.
Make sure that his team represents Syngenta in the local industry associations, actively participate and regularly report on any topic relevant to the company.
Ensure that trial work timelines are aligned with regulatory ones by working closely with EASA CPD/Product Biology team.
Proactively manage or carry out product-related issue for EASA and coordinate the mitigation plan.
Support BA Customer Service/Order Management on regulatory matters (shelf-life extensions, country of origin issues, review of inspection certificates, etc.)
Qualifications
Knowledge, Experience & Capabilities
Critical Knowledge
Degree in Science/Agriculture or relevant technical qualification.
Good knowledge of regulatory requirements and trends in NG.
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.
Critical Experience
Experience in regulatory affairs – gained through 3 years direct experience in a regulatory role; or through significant technical experienced gained in the BU.
Demonstrated strengths in communication, self-organization and problem solving.
Developed negotiation/influencing skills across different cultures
Good level of business understanding & competence.
Critical 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 details 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.
Critical Leadership Capabilities
Strong leadership capabilities
Structured mind,
Creative and growth mindset
Transparency in communication
Collaborative mindset (team work)
Effective and efficient communication with key stakeholders;
Ability to develop new ideas and challenge existing concepts, strength in planning and time management and excellent organizational skills.
Critical success factors & key challenges
Acquire good knowledge of the registration requirements in AME territory in general.
Get acquainted with processes and tasks in AME regulatory.
Acquire regulatory know-how and knowledge on watchouts of ais and products;
Show ability to work accurately and to deliver dossiers/special tasks on time and up to Syngenta standards.
Ensure best freedom to operate (advocacy and license to sell (registrations) in countries).
Show ability to manage and coach a team or colleagues on need.
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