Head of Business Development

PILLARS; Gauteng; On-site; ZAR 500,000 - 600,000; Full time

Job summary

A leading international company is seeking a local representative in South Africa to oversee regulatory affairs, establish operations, and develop market strategies for their diagnostic products. The role involves managing product registration with authorities, conducting feasibility studies, and building a local team by the end of Month 3. Candidates must have experience in regulatory affairs and strong planning skills.

Qualifications

• Experience with regulatory affairs and product registration processes.
• Ability to perform market analysis and feasibility studies.
• Strong HR management skills to build a local team.

Responsibilities

• Manage regulatory affairs with the South Africa Drug Authority.
• Prepare and submit a comprehensive feasibility study including market analysis.
• Develop the HR and organizational plan for South Africa.

Job description

Objective

To establish The company presence in South Africa and lay the foundation for long-term operations in North and Sub-Saharan Africa, with full regulatory, operational, and strategic responsibilities as the Company's local representative.

Key Responsibilities and Deliverables

1. Regulatory Affairs and Product Registration: this step should be number 2 as it starts after the legal presence
   • Communicate directly with the South Africa Drug Authority to initiate and manage the registration process for The company IVD products.
   • Collect and submit all required technical documentation, in alignment with MOH standards.
   • Coordinate with The company QA/RA teams to localize dossiers and fulfill any translation/legalization requirements.
   • Company Incorporation and Local Setup (a meeting to be held with the legal firm explaining the best fit for a legal presence depending on The company strategy to the South African market and then agree on the presence and based on that The company start providing the power of attorney and afterward we agree on a primary timeframe to finalize the company and I work parallels to find the company location accommodating 10 employees)
   • Lead the feasibility and legal structuring for the establishment of a local entity (LLC, Branch, or Representative Office).
   • Coordinate with certified legal firms or business consultants to prepare and submit all incorporation documents.
   • Secure a suitable commercial office space for The company operations (including lease negotiations).
   • Oversee the registration with local tax, social insurance, and commercial registration authorities.
   • Deliver a comprehensive legal and operational report outlining steps, timelines, and costs by end of Month 1.
2. Feasibility Study and Work Plan
   • Prepare a Feasibility Study (FS) including:
   • Market analysis
   • SWOT assessment
   • Legal requirements
   • Risk assessment
   • Budget estimation
   • Submit a detailed Gantt chart covering all deliverables and dependencies within the first two weeks of the contract.
   • Use FS and timeline as the basis for budget planning and performance evaluation.
3. Human Resources and Team Structure
   • Develop an HR and organization plan for South Africa
   • Identify, interview, and shortlist candidates for roles in:
   • Sales and marketing
   • Regulatory affairs
   • Admin/support
   • Prepare a team structure proposal with job descriptions and compensation benchmarking by end of Month 2.
4. Market Development and Customer Outreach
   • Design the local go-to-market strategy for The company diagnostic kits and instruments.
   • Identify and establish contact with:
   • At least 5 diagnostic laboratories
   • At least 3 potential distributors
   • Conduct on-site or virtual meetings to introduce The company product lines.
   • Provide a customer database with engagement logs.
5. Business Model Design for Africa
   • Create a strategic business model for The company entry into the broader African market, including:
   • Target countries and channels
   • Import/export logistics
   • Pricing structures
   • Partnership opportunities
   • Present a draft expansion strategy by the end of Month 3.

Reporting Requirements

• Regulatory Update: Status of MOH communication, submitted files, expected timelines — Bi-weekly Mondays
• FS & Gantt Chart: Market/operational feasibility & timeline — Once Week 2
• Market Report: Labs, distributors, pricing benchmarks — Monthly, End of each month
• HR Plan: Team proposal, roles, salaries — Once, End of Month 2
• Incorporation Log: All steps of company setup with documents — Monthly, End of each month
• Final Summary Report: Full summary of all tasks, progress, recommendations — Once, End of Month 3
• Performance Benchmarks (KPIs)
  • Submission of at least 2 product registration files to MOH regulatory
  • Submission of feasibility study and Gantt chart within first 2 weeks
  • Completion of company incorporation steps by Month 3
  • Identification of at least 5 laboratory leads and 3 distributors
  • Submission of complete HR and market development plan
  • Adherence to reporting schedule without delay

Contractual Conditions

• This Scope of Work is binding and forms an integral part of the Employment Agreement.
• If performance milestones are not met, the Company reserves the right to withhold related monthly payments.
• All work shall be carried out exclusively and full-time by the Employee, with no competing engagements during the term.