Regulatory Specialist: Herbicides

2 weeks ago

Durban, KwaZulu-Natal, South Africa UPL ltd Full time

Regulatory Specialist:

Herbicides:
Job Id: 6957- City: DURBAN, KwaZulu-Natal, South Africa- Department: R&D Regulatory - Registrations- Function: Regulatory, Research and Development- Employee Type: Permanent Full Time- Seniority Level: Mid-Senior level- Description:


  • Role Profile

Job Title Regulatory Specialist:
Herbicides

Designation Individual Contributor

Reporting To Formulation and Regulatory Lead Southern Africa

Skip Level Reporting Regulatory and Development Head, AME

Function Regulatory

Location Durban, South Africa

Role Summary

Role Responsibilities
Regulatory Compliance

  • Maintain the Herbicide, IVM, Adjuvant, Fumigant and Rodenticide portfolios under regulatory and legislative compliance within the geographic region under scope, i.e., South Africa (ZA).
  • Ensure registration of new products and maintain registrations of existing products within assigned portfolio/s within ZA.
  • Prepare, i.e., collect, evaluate (accuracy and integrity), organize, collate and maintain scientific, legal and regulatory information/data in a variety of formats, including but not limited to electronic databases and physical files, related to portfolio of products.
  • Ensure that the associated project regulatory expenses are paid ontimeinfull, in collaboration with R&D Administration Officer.
  • Report regularly (daily, weekly, monthly) on the status of products or projects and provide responses to questions/queries/correspondence to internal (management, other departments) and external stakeholders (headquarters, regulatory authorities) related to portfolio.
  • Work in Partnership and provide guidance to crossfunctional teams such as Technical Product Development, Marketing and R&D PMO on regulatory requirements and the associated costs for submission of new business cases.
  • Liaise with Formulation Development for inhouse product development and sample requirements for regulatory studies.
  • Ensure that suppliers of formulations and active ingredients meet the needs of ZA regulatory requirements.
  • Schedule and manage portfolio related product renewals on an annual basis.
  • Compile SDS's for new products and maintain updates for existing products.
  • Keep up to date with changes in regulatory legislation and guidelines and inform relevant internal and external stakeholders.
  • Ensure that quality standards are met, and submissions meet strict deadlines.
  • Support ad hoc requests relating to regulatory functions and related company initiatives.
  • Support other regulatory Portfolios/New Portfolio/New Product Category (hybrid products) based on company needs, seasonal workload, and company financial necessity.
  • Promote teamwork, communication and foster a knowledge sharing culture.
  • Be actively involved in all regulatory EDER (Early Detection, Early Resolution), activities, e.g. (including but not limited to) sudden changes in legislation such as implementation of GHS, or CMR molecules phaseouts. Provide early warning to business on regulatory trends, decisions, and possible impact.
  • Responsible for the compilation of highquality dossiers and/or submissions.
  • Create, modify, and maintain operating procedures and processes pertaining to specific portfolio, with agreement of Subregional Regulatory Head.
  • Escalate all delays to Subregional Regulatory Head and Regional Regulatory Head
Label Management

  • Draft and maintain GHS compliant labels for new product registration submissions as well as for amendments to existing products.
  • Liaise with Supply chain Label Coordinator on printing of labels for new registered products.
  • Provide supporting data for uploading and updating the global artwork management systems, e.g., Karomi and local marketing platforms
  • UPL Website and Agri-Intel.
AGRI-INTEL

  • Responsible as single point of contact for UPL with Agriintel. To ensure latest updated product label information is submitted timeously to Agriintel.
Contracts and Agreements

  • Ensure that all contracts and agreements are maintained for product portfolio registrations
General

  • Maintain physical and virtual files, trackers, Gannt charts, support with timeous information for monthly/quarterly/other frequency management/stakeholder update.
  • Maintain confidentiality of all sensitive information.

Knowledge, Skills and Experience Required

  • Two to three years of experience in individual or team orientated projects in a sciencebased environment
  • Minimum of B.Sc. but preferably a postgraduate qualification (Hons. or M.Sc.) in Crop, Microbiology or Chemical sciences
  • Any experience in Project Management or team supervision would be an advantage but not a necessity.
  • Detail orientated and analytical is key to meet the high level of accuracy required for regulatory compliance. Working in a solution driven environment requires a selfmotivated and persistent individual with a high level of creativity to work towards factbased problem solving.
  • Good sense of ti

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