Regulatory Manager

Company Description

As a world market leader in crop protection, we help farmers to counter these threats and ensure enough safe, nutritious, affordable food for all while minimizing the use of land and other agricultural inputs. Syngenta Crop Protection keeps plants safe from planting to harvesting. From the moment a seed is planted through to harvest, crops need to be protected from weeds, insects and diseases as well as droughts and floods, heat and cold. Syngenta Crop Protection is headquartered in Switzerland.

Job Description

Role purpose

Achieve, extend and maintain license to operate (registrations) for Syngenta products in areas of responsibility within agreed timelines, under the supervision of the Regulatory Lead.
Provide regulatory expertise and foresight to the business, coordinated by the Regulatory Lead.
Plan and execute regulatory activities in areas of responsibility and find innovative registration approaches within the legal regulatory framework.
Secure Syngentas competitive edge through top quality submissions and handling registration issues in an ethical, trustworthy way in cooperation with country authorities.

Accountabilities

Manage the registration activities for countries in the business area, as defined by the Regulatory Lead. This includes the preparation of registration submissions; answering requests from authorities; covering regulatory aspects of product labelling and formulation/source changes; keeping Syngenta internal registration databases up to date.
Plan, achieve, maintain and defend approvals / registrations (for new registrations, reregistration, label extensions and formulation changes) of Syngenta Portfolio in South Africa, Namibia and Botswana to the appropriate approval authority. Aiming to meet business objectives within agreed timelines and in compliance with local statutory requirements.
Provide regulatory expertise and foresight to the business. Keep regulatory and business informed on regulatory changes and emerging issues which require proactive management.
Jointly develop and implement, with the Regulatory Lead, a robust freedom to operate (FtO) approach across countries in the business area, aligned to Global strategy incl. stewardship & safe use.
Provide to the Regulatory Lead annual plans, timelines and budget needs for all registration activities in-line with portfolio strategy/priorities. Track, review and report registration progress against targets.
Establish a network with regulatory authorities, to represent company interests. Maintain close contact with local partners and stakeholders in order to grow and maintain expertise of national registration processes and legislations.
Proactively manage product related issues.
Support supply chain and other internal stakeholders on regulatory matters (shelf-life extensions, country of origin issues, review of inspection certificates, etc.).
Accountable for regulatory compliance within the allocated countries, including liaison with external stakeholders on regulatory compliance matters/enquiries
Develop, drive and implement effective processes and SOPs to ensure regulatory compliance in accordance with local legislation throughout the product life cycle
Support, in case of need, the Regulatory Lead in engagement and participation in the local Industry association.
Work in partnership with Product Biology counterpart to ensure that regulatory submissions of the highest quality are submitted to the regulatory authorities.

Qualifications

Knowledge, Skills & Experience

Critical Knowledge

5+ years regulatory experience.
Expert knowledge on PPP legislation and PPP authorization in South Africa, Namibia and Botswana and at EU level.
Knowledge of the technical disciplines related to PPP registration, toxicology, product residues, environmental fate and ecotoxicology at a general level.
General understanding of agriculture industry.
Deliver value adding solutions to the business in countries of responsibility.
Effective collaboration within the regulatory team and with supported business functions
Internal & external networking.
High attention to detail whilst keeping the overview.
Capability to provide impact assessment of local and global Regulations on the Business Area, in order to develop strategic & sustainable action plans to maintain Syngenta freedom to operate.

Critical Technical, Professional And Personal Capabilities

Capability to work in a highly structured and independent manner
Excellent administrative skills (attention to detail whilst maintaining the overview)
Strong management capabilities
Analytical and strategic thinker
Ability to act in a trustworthy and responsible manner
Ability to multitask on different levels whilst being results orientated
Networking capabilities to effectively build and maintain a solid internal and external network
Team player, enjoying collaboration with the line manager (Regulatory Lead) and the other functions locally and internationally
Effective Decision making
Ability to prioritize and deliver goals on time
Demonstrate strengths in communication, self-organization and problem solving and developed negotiation/influencing skills across different cultures
Good communication in English

Minimum Education And Critical Knowledge Required For The Job

Scientific degree in Environmental Science, Ecology, Chemistry, Biology or Agriculture (Bachelor, Master or PhD) or relevant technical qualification.
SACNASP Accreditation as a Professional Natural Scientist (Pr. Sci. Nat.) in a relevant scientific domain.
Good knowledge of regulatory legislation and requirements in the crop protection industry; gained through direct experience in a regulatory role; or through significant technical experience
Good knowledge of GLP OECD principles and GEP principles.
Additional relevant qualification an added benefit
Proven registration activities experience
Project management experience
Proven relationship management capabilities
Proven cross-functional working capabilities
Proven experience in providing solutions to complex issues
Proven communication, negotiation, influencing and analytical capabilities

Experience To Be Gained In The Job

Acquisition/enhancement of the knowledge on registration requirements and regulatory developments in the EU and impact on the South African BA.
Direct contact with business units in the countries, which will provide a good insight of the different market segments and CP industry in Africa
Enhanced advocacy skills, strategic and sustainable mindsets
Enhanced capability to assess the impact of a regional regulatory system on another territory (ie EU on AME)

Relevant Legislations Including, But Not Limited To

South Africa:

Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 Of 1947
Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 Of 1972) Regulations Governing the Maximum Limits for Pesticide Residues That May Be Present In Foodstuffs
Occupational Health and Safety Act, 1993 Regulations for Hazardous Chemical Agents