Regulatory Specialist: Export Countries, Southern

2 weeks ago

Durban, KwaZulu-Natal, South Africa UPL NA Inc. Full time
Job Id: 8972- City: DURBAN, KwaZulu-Natal, South Africa- Department: Regulatory Operations- Function: Regulatory Science & Government Affairs- Employee Type: Permanent Full Time- Seniority Level: AssociateDescription:

Job Title Job Title:
Regulatory Specialist - Export Countries, Africa

Designation Location:
Durban, La Lucia

ABOUT UPL:

_UPL is focused on emerging as a premier global provider of total crop solutions designed to secure the world's long-term food supply. Winning farmer's hearts across the globe, while leading the way with innovative products and services that make agriculture sustainable, UPL is the fastest-growing company in the industry. Our successes in the field add up to powerful financials. UPL delivers results from protecting crops that translate into attractive investor value. Based on the recognition that humankind is one community, UPL's overarching commitment is to improve areas of its presence, workplace, and customer engagement._

_Our purpose __is_
_ 'OpenAg'. __An agriculture network that feeds sustainable growth for all._
_ No limits, no borders._

_We are one team, for maximum impact. One team with shared goals. We have a laser-like focus on what our customers need and want, on anticipating their future needs, and on how we can create innovative solutions and experiences for them. We think outside the box and go beyond our comfort zone. We believe in agility, we mix the power of speed, with structure from process. And wherever we can, we always believe in having fun._

Role Summary


Manage routine activities, including but not limited to, studying, and compiling scientific and legal documents to ensure that products are in compliance with the respective governmental regulations.

Work in partnership with the Technical & Development Lead:

Export Countries & Dossier Powerhouse on new project developments to ensure that all regulatory requirements are fully achieved to complement biological development in accordance with submission timelines and forecasted regulatory project budgets.


Role Responsibilities
Regulatory

  • Maintain the Southern African Export Countries portfolio under regulatory and legislative compliance within the geographic region under scope, i.e., Zambia, Zimbabwe, Malawi, Namibia, and Botswana.
  • Ensure registration of new products and maintain registrations of existing products.
  • 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 the respective country 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 need, 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 t

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