Regulatory Specialist: Export Countries, Southern Africa

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 on-time-in-full, 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 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.
• Liaise with Formulation Development for in-house 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 phase-outs. Provide early warning to business on regulatory trends, decisions, and possible impact.
• Responsible for the compilation of high-quality dossiers and/or submissions.
• Create, modify, and maintain operating procedures and processes pertaining to specific portfolio, with agreement of Sub-regional Regulatory Head.
• Escalate all delays to sub-regional 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., Local marketing platforms - UPL Website and Agri-Intel.

Document Courier

• Responsible to courier documents to and from the regulatory authority offices and/or 3rd party stakeholders and confirm receipt and collection of documents, as well to timeously communicate any feedback from ACT 36 to manager.

Contracts and Agreements

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

Other

• 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.

Responsibility Weightage and % of Time Spent Matrix

Strategic:                                                        Strategic 35%; Tactical 65%

Number of Direct Reports:                         0

Number of Indirect Reports:                      0

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 sites]to avoid delays in registration submissions.

       Dossier Powerhouse

• To collaborate on all projects that are allocated to Dossier Powerhouse for support.

      Supply Chain

• Compliance in addition of new sources and suppliers Liaise with local, regional and global SCM regarding Letters of supply for renewals process.

      Regulatory Authority

• Maintain high quality interactions and professional relationships with registrar's 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 portfolio.

Analytical services

• Initiate and monitor physchem, 5-batch studies and related studies, globally and locally.

CropLife, Fertasa, SABO etc:

• 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:

• Two to three years of experience in individual or team orientated projects in a science-based environment.
• Minimum of BSc but preferably a post-graduate qualification (Hons. or MSc) in Agricultural, Microbiological or Chemical sciences
• Any experience in Project Management or team supervision would be an advantage but not a necessity.
• Communication and collaboration at multiple levels in the organization and departments.

Behavioural Requirements

• 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 self-motivated and persistent individual with a high level of creativity to work towards fact-based problem solving.
• Good sense of time-management and prioritization skills to support diverse projects running in parallel.
• Integrity and a professional approach to work.

UPL Competencies 

• Adaptability & Resilience

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.

• Entrepreneurial Mindset 

Has a creative mindset and ability to think holistically, takes calculated risks and maximizes opportunities.

• Results Orientations

Acts, pursues goals with persistence and achieves results; communicates goals and vision to the team to drive enthusiasm and ambition.

• Execution Excellence

Enhances the speed of execution and builds efficiency in processes, systems, and people; has sharp focus on quality-orientation.

• Strategic 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.

• Building Teams and Talent

Empowers colleagues through knowledge sharing and delegation, quickly establishing rapport; provides recognition for achievements and accomplishments.

• Customer Centricity

Understands the customer needs and pain points, fulfills the needs and expectations by focusing on creating value for customers.