Regulatory Lead - EASA at Syngenta

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

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.
• Ensure qualitative and compliant dossier submission by setting up efficient REG operations and continuous improvement initiatives
• 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, 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.

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.