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Head: Regulatory & Technical Development

Kwazulu Natal , R80000 - R150000 Per Month
Sector: Agriculture
Posted: Thursday, 5 May 2022

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Job Details

Job TitleHead: Regulatory & Technical Development - Southern AfricaDesignation/GradeManagerBand5Reporting toRegional Head: Product Development & Regulatory - AMESkip level ReportingGlobal Head - Product Portfolio DevelopmentFunctionProduct DevelopmentIf selected others above please mention the function LocationLa Lucia, Durban     SECTION II: PURPOSE OF THE ROLEPlease fill in the informationPurpose of RoleProvide technical and regulatory guidance for new product development proposal in association with R&TD and Marketing. Provide oversight in preparing the associated budget with consideration of technical and regulatory requirements. Manage R&D Capex and SG&A expenses within set budget. Management of the Technical and Regulatory functions for full compliance with regulations and performance in project management to meet buisness objectves as agreed with Marketing. Facilitate cross-departmental interaction to allow R&TD to provide guidance and act proactively in maintaining compliance.  Manage the process for investigation and resolving product performance claims Strategic : Tactical %50% Strategic: 50% Tactical     SECTION III:  JOB REQUIREMENTS Please fill in the informationTotal Experience in Yrs. (Minimum required)10 to 12 years in Project mangement for technical product development and regulatory compliance. This should be inclusive of four to five years experience in mangaging a reporting team.QualificationMinimum of an M.Sc. preferably in agricultural sciences. A post-graduate business qualification or formal training in business skills will be an advantageSpecific or Additional Certifications (if Any) requiredCropLife Basic Crop Protection certificateTechnical Skills RequirementOrganizing and managing a multifunctional team and developing individuals to function automonous within their respective disciplines. Expert knowledege of product development methodolgy as well as all guidelines and regulations required for compliance under Act 36 of 1947 as well as any additional requirements within the country legal framework for crop protection chemicals. Above average knowledge of major crops and their associated disease, insect and weed control requirements. Basic understanding of business finance and business legal processes and requirements.    Behavioral Skills RequirementDetail orientated, analytical with a high level of accuracy in planning projects and managing of biological trials programs. Self-motivated and driven to find solutions in executing development projects in a practical manner within set budget and timelines. Creativity and flexibility in addressing challanges that arise during project planning, project execution and in compiling of data dossiers.  Ability to prioritize and manage activities within set timelines. Ability to analyze development needs of individuals and promote a culture of continuous improvement within teams and work streams.  Category of roleHead QuartersCategory of job (applicable for US only)      SECTION IV: SCOPE OF JOB / QUANTIFIABLE DIMENSIONS OF THE JOBPlease fill in the informationFinancial Accountability$1mio p.a. for product development and $280k p.a. for annual R&D overhead costsGeographical CoverageSouthern AfricaNumber of Direct Reports NineNumber of Indirect ReportsTwo<Other>      SECTION V: ROLES & RESPONSIBILITIESPlease fill in the informationResponsibilityAreaResponsibilityWeightage% of Time Spent Product Development: Guide the concept development to be inclusive of all requirements for successful product registrations. Set and monitor the budget and project time lines to deliver all biological and regulatory data as agreed. Build strong and sustainable relationships with well performing CRO's and laboratory services to ensure that company requirements are dealt with as priority.  Promote a culture of continuous improvement through training to keep abreast of advances in crop, product and R&D technologies, 5050% Regulatory: Ensure proactive involvement of Regulatory with the development process to acquire and / or initiate studies in support of a successful and complete submission. Facilitate interaction with Marketing, Supply Chain and Production to manage formulation and source changes to maintain regulatory compliance. Foster an environment wherein the regulatory team members can function in a self-directed manner and build knowledge networks to fully contribute to the compliance and product development processes. Promote a culture of continuous improvement through training and following changes in the local and global regulatory frameworks. 3030% Product performance claims: Conduct and coordinate activities to investigate and report on circumstances and probable causes. Trigger any required external services to broaden investigation. Inform and involve legal and insurance as required. Using all facts and evidence make a logical and fair conclusion on causes of complaint. Where required and in case of any form of liability negotiate a settlement.  1010% IP: Implement the required processes ensuring protection of existing IP, internally and externally. Conduct FTO analyses on new developments for the region and provide technical input if and when new developments are deemed patentable.  55% Legal: Fulfill and comply with requirements dictated by development and supplier contracts. Seek advice and comply with legal requirements to not prejudice the company with respect to product performance claims and settlements.  55%  Total:100%Any Other Job Related Details           SECTION VII:  KEY INTERACTIONSPlease fill in the informationInternal StakeholdersGlobal Technical / Regulatory / Marketing: Local development requirements. Progress in project development. Participation in global projects. Technical advice and alignment.R&TD Team: Setting function objectives, monitor progress and provide support and guidance to ensure the required targets are met on time. Provide mentoring to optimize individual performance. Setting and monitor of of processes to manage continuous compliance with laws and regulations Marketing and Commercial: Define development needs and communicate progress. Technical advice. Managing of product perforance complaints/SCM / Production / Formulation Development: Formulation and source compliance. Formulation optimization and changes to enhance regulatory compliance. New formulation development.External Interactions Regulatory Authority: Follow changes in regulations. Address technical queries in support of submitted dossiers . Third Party Suppliers: Agree on development needs and manage associated projects. Regulatory support. Facilitate daughter registration contracts where relevantEngage with lawyers, insurers and assesors in resolving product performance claims Trial contractors and service laboratories: Relationship management to ensure company demands are handled as priority      Preferred Sectors for talentFrom Agrochemical Industry or chemical industry