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Job Title Registration Specialist: Herbicides IVM & Adjuvants
Designation Registration Specialist: Herbicides IVM & Adjuvants
Reporting To Head of Regulatory Southern Africa
Skip Level Reporting Regulatory Head Africa
Function Regulatory
GJL GJL 3
Location Gauteng or KwaZulu-Natal
ABOUT UPL:
UPL is focused on emerging as a premier global provider of total crop solutions designed to secure the worlds long-term food supply. Winning farmers 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 UPLs 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 allocated to Herbicide IVM and Adjuvant portfolio are in compliance with governmental regulations. Work in partnership with the Project Lead: Herbicides Seed Treatment Fumigants Adjuvant & IVM 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
1. Maintain the Herbicide portfolio under regulatory and legislative compliance within the geographic region under scope i.e. South Africa (ZA)
2. Ensure registration of new products and maintain registrations of existing products within assigned portfolio/s within ZA.
3. 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.
4. Ensure that the associated project regulatory expenses are paid on-time-in-full in collaboration with R&D Administration Officer.
5. 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.
6. Work in Partnership and provide guidance to cross-functional teams such as Technical Product Development Marketing and R&D PMO on regulatory requirements and the associated costs for submission of new business cases.
7. Liaise with Formulation Development for in-house product development and sample requirements for regulatory studies.
8. Ensure that suppliers of formulations and active ingredients meet the needs of ZA regulatory requirements.
9. Schedule and manage portfolio related product renewals on an annual basis.
10. Compile SDSs for new products and maintain updates for existing products.
11. Keep up to date with changes in regulatory legislation and guidelines and inform relevant internal and external stakeholders.
12. Ensure that quality standards are met and submissions meet strict deadlines.
13. Support ad hoc requests relating to regulatory functions and related company initiatives.
14. Support other regulatory Portfolios/New Portfolio/New Product Category (hybrid products) based on company need; seasonal workload and company financial necessity.
15. Promote teamwork communication and foster a knowledge sharing culture.
16. 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 phase-outs. Provide early warning to business on regulatory trends decisions and possible impact.
17. Responsible for the compilation of high quality dossiers and/or submissions.
18. Create modify and maintain operating procedures and processes pertaining to specific portfolio with agreement of Sub-regional Regulatory Head.
19. Escalate all delays to sub-regional Regulatory Head and Regional Regulatory Head
Label management
1. Draft and maintain GHS compliant labels for new product registration submissions as well as for amendments to existing products.
2. Liaise with Supply chain Label Coordinator on printing of labels for new registered products.
3. Provide supporting data for uploading and updating the global artwork management systems eg. Karomi and local marketing platforms - UPL Website and Agri-Intel.
Document Courier
Contracts and Agreements
Any Other Job Related Details
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.
Have an in-depth knowledge of relevant regulations and requirements for submission of registration applications
Individual/Team
Strategic 20%: Tactical 80%
Responsibility Weightage and % of Time Spent Matrix
Responsibility
Weightage
% of Time Spent
Regulatory
80
80%
Label Management
10
10%
Document Courier
5
5%
Contracts and Agreements
5
5%
Internal Stakeholders
Technical Project Leads and Marketing
Manage and provide guidance on regulatory requirements related to new projects and to ensure submission timelines are met. Data gap analysis budgeting and financial administration relating to regulatory project costs.
Reg. Compliance manager
Liaise on a regular basis to ensure that the required actions are triggered to address data gaps in regulatory information sources and formulators and formulation sitesto avoid delays in registration submissions.
Supply Chain
Compliance in addition of new sources and suppliers Liaise with local regional and global SCM regarding Letters of supply for renewals process.
External Interactions
Regulatory Authority: Maintain high quality interactions and professional relationships with registrars office is of paramount important to business.
1. Submission of data waivers.
2. Clarification of registration requirements.
3. Resolving queries on existing registrations as well as for new submissions.
4. Follow-up on projects submitted within porfolio.
Analytical services: Initiate and monitor physchem 5-batch studies and related studies globally and locally.
Crop Life: Participate in Work groups and contribute towards development of guidelines and governance requirements for the CP industry
Marketing SHE F&D QC
Suppliers: Liaise and maintain good working relation with suppliers to ensure all input regulatory data is accurate and up to date. Requesting information on active ingredients and formulations for regulatory compliance.
Knowledge Skills and Experience Required
Technical Requirements:
Behavioural Requirements
UPLCompetencies
Recognizes and is open to changing circumstances and alters behavior and scales up as necessary; increases personal awareness and appreciation of individual and cultural differences to create an open inclusive and accepting workplace
Has a creative mindset and ability to think holistically takes calculated risks and maximizes opportunities
Acts pursues goals with persistence and achieves results; communicates goals and vision to the team to drive enthusiasm and ambition
Enhances the speed of execution and builds efficiency in processes systems and people; has sharp focus on quality-orientation
Demonstrates knowledge of the social economic and environmental factors and how they impact the business. Identifies key issues that could impact the business and develops strategy through an analytical lens / design thinking
Empowers colleagues through knowledge sharing and delegation quickly establishing rapport; provides recognition for achievements and accomplishments
Understands the customer needs and pain points fulfills the needs and expectations by focusing on creating value for customers.
Required Experience:
Unclear Seniority
Full-Time