Job Description

Regulatory Compliance Specialist, AME

Job Id: 8188



City: 04001, Gauteng, South Africa



Department:



Function: Regulatory, Research and Development



Employee Type: Permanent Full Time



Seniority Level: Associate







Description: Job Title Regulatory Compliance Specialist Designation/Grade Specialist Band Level 4 or 5 Reporting to Regional Regulatory Head Africa Location South Africa Olifantsfontein Johannesburg
Purpose of Role

• To implement and manage the processes with which UPL can comply with Regulatory requirements and internal policies related to product source verification and GHS compliance.

• Manage the renewal of all products on an annual cycle and keep database updated.

• Managing and ensure uninterrupted business continuity with regards suppliers/vendors and valid registration renewals.

• Replenishment cycle planning requires coordination across supply planning, manufacturing, toller manufacturers and the vendors in that material is delivered to site in the correct quantity and at the right time whilst maintaining a high-level focus on net working capital. Interface between Production Planning and Procurement to ensure collaboration in achieving the medium- and short-term plan via analysis on the Supply network plan (SNP) and therefore meeting Business OTIF (On Time in Full measure) to UPL customers. Attention to details at various levels of the supply chain function to ensure that the purchase order proposals are accurate, and the materials are purchased timeously to meet the business demands in a very dynamic organisation, whilst identifying and driving actions to improve the supply and availability of materials. Position requires a high level of focus and attention to detail both on procurement excellence and operational execution.

JOB REQUIREMENTS Total Experience in Yrs. (Minimum required)

• 2 to 4 yearsxe2x80x99 working experience in a corporate Regulatory Compliance Environment.
• Suppliers/Vendors contacts and Renewal compliance. R & D Experience would be an advantage.

Qualification

• Bachelorxe2x80x99s degree in agriculture.

Specific or Additional Certifications (if Any) required:

• SACNASP accreditation & GHS training certificate. CropLife Course would be an advantage.
• Experience in Regulatory compliance & Supply of products.
• Artwork & Design Coordination with Supply Chain.
• GHS training to get all products GHS compliant.
• Chemical background to evaluate documentation for registration of Additions Suppliers/Vendors.
• Familiarity with company Policies, Procedures, Product range, Tools, Learning Modules & Codes.

Behavioral Skills Requirement

• Demonstrate a strong drive to operate and engage with cross functional teams to deliver improvements.

• Attention to detail. Methodical analytical capabilities.

• Ability to work under pressure in volatile environment /situations & ability to adapt to regular Guideline changes.

• Proficiency in time management.

• Strong Communication Skills

• Customer focus.

• Individual & self-development

• Collaborative teamwork.

• Result orientated.

• Strong negotiation skills.

• Interpersonal skills.

• Adapt to Change Management.

• Professional level of spoken and written English as per the Site language.

SCOPE OF JOB / QUANTIFIABLE DIMENSIONS OF THE JOB Financial Accountability

• Validation of documentation for adding sources/vendors according to budget forecast.
• Forecasting for suppliers/vendor submissions.
• Vendor Conformance to be added as Suppliers of Quality products.

Geographical Coverage Southern Africa & Assistance to Africa Region
ROLES & RESPONSIBILITIES Regulatory Compliance

• Ensure Renewal of product registrations and supply of relevant documentation to support submissions.

• Escalate any risks in supply horizons of Suppliers/Vendors unwillingness to supply, renew supply due to merger of companies and name changes. All product suppliers/vendors must be kept updated. Escalate problematic suppliers to procurement for resolution.

• Liaise with Global and Regional procurement, decide on remedial action and implement steps to correct non-compliance. Timeous communication of potential risks and delays and their impact on business, to management.

• Review with Supply chain the portfolio of products that are required to be renewed and additional Suppliers/Vendors to be registered.

xe2x80xa2Get Suppliers/Vendors registered within lead-time of placing orders to secure supply date. xe2x80xa2Ensure all new sources and formulators are registered and documented.

• Liaise with Supply chain to ensure alignment with registration requirements.

• Facilitate the process of obtaining data such as five batch analysis, method of analysis and six pack studies.

• Evaluate and validate data to ensure that it meets regulatory standards.

• Maintain data base/REGONE and Master data with up-to-date information.

• Provide compliance support to all other departments within the company.

• Ensure confidentiality agreements/contracts related to product sources are subject to appropriate legal review.

• Compile and provide accurate source data for inclusion in registration dossiers."

• Provide back-up support to Regulatory Team members when needed.

Source/Vendor registration

• Collaborate with UPL Global in terms of additional Suppliers/Vendors.

• Collaborate with Supply Chain Managers on preferred Sources/Vendors in terms of pricing and availability.

• Review costs of adding additional Suppliers/Vendors and coordinate renewal costs annully. Ensuring all approvals within validity period.

• Maintain Supplier index with contact information on REGONE.

• Close collaboration with Procurement and Regulatory on any spec differences in quoted materials for escalation and approvals.

• Handle requests for registration of products.

• Investigate, validate, and communicate with laboratory regarding product information.

• Assist with Dossier preparation for other African Countries.

GHS compliance

• Assessment of product characteristics and classify according to GHS requirements to the highest level of accuracy.

• Apply knowledge for GHS classification and support the Regulatory team members with compliance on Labels & SDS's.

• Implement steps and processes to ensure that GHS compliance requirements are achieved.

If conflicts should arise in normal application of GHS principles to specific product combinations apply fact-based calculations to achieve a rational conclusion. "

• When non-compliance cannot be resolved - problem to be referred to management. If defined GHS classification cannot be achieved, then elevate for external verification.

Reporting and Projects

• Work closely with Registration Department on new product launches, alternative or substitutions approvals.

• Monitor product renewals, analyse, and report upon any non-compliance to management.

• Facilitate between Quality Control (QC)/Warehouse and Factory on Supplier non-conformance complaints.

• Collaboration/reporting on approval of additional suppliers/vendors to Regulatory and Supply chain.

Any Other Job-Related Details

• This role will require the candidate to collaborate closely with the Regulatory Team, Supply Chain, The Registration Authorities and Suppliers/Vendors plus Global UPL team in terms of integrated business.

• Planning and supporting business targets.

KEY INTERACTIONS Internal Stakeholders Supply Chain & Procurement:

• Liason to support required additional Suppliers/Vendors, to ensure quality products and availablity to Procurement.
• Optimization on Supply possibilities.

Regulatory & Regulatory authorities:

• Across the company (Local and Global). Maintaining the Registered Supplier/Verndor list and Trade licence of each product.
• Ensure compliance.
• Master data management to request and assist in new data needed to procure/manufacture new or amended items

Commercial Team:

• Support with source/vendor changes plus GHS compliance, changes in labels /certifications and management of change.
• Analyse demand proposals in line with interactive plans and supply plans for risk aversion.

External Interactions: Suppliers/Vendors:

• Interaction on documentation, schedule submissions and reliable quality products.
• Document coordination and submission timelines.
• Interaction with the Registration authorities on renewals and addition suppliers/vendors and formulation sites.
• Scientific laboratories (both local & international)."

Preferred Sectors for talent

• From Chemical/Regulatory within Agrochemical Industry