Regulatory Affairs Specialist

Locations: South Africa or Kenya

Remote

12 Months Fixed Term Contract, Full time

Company Description

Consultancy – Health Products

Vicore is a health product industry service and technology provider, specialising in Healthcare Strategy, Regulatory Affairs (incl. Pharmacovigilance), Quality Assurance and Medical Affairs solutions. Vicore helps to facilitate a total end-to-end solution for health product manufacturers with long-term valueadding strategic partnerships in place, such as Technology, Demand Generation, Supply and Logistics.

Regulatory Affairs Specialist Vacancy

Vicore currently has a vacancy open for a Regulatory Affairs Specialist role.

Role Purpose

Mid-level position, responsible for the technical aspects and deliverables of an exclusive Client Project.

Role Outputs

For the role, the following outputs apply:

• Assisting with compilation services (i.e. Compiling and submitting new product applications, generic applications, new indication or line extension applications to the relevant NRAs, ensuring that registration requirements are fulfilled).

• Assisting with the maintenance of Marketing Authorisations and licenses in compliance with local regulations and ensuring that client regulatory licenses, processes, SOPs and systems are compliant and followed.

• Assisting with the compilation of name-patient and unregistered medicine applications for regulatory submission.

• Aiding the research and continuity of Regulatory Intelligence activities across the required markets (existing and new), and communicating it to the relevant stakeholders or departments.

• Ensuring cross-functional alignment on regulatory approvals and product availability for launch and distribution.

• Contribute to discussions on relevant RA topics and communicate closely with other departments.

• Working efficiently and accurately within regulatory software and systems.

Competency and Skill Requirements

For the role, the following competencies and skills are required:

• Experience: A minimum of 2 years’ Regulatory Affairs experience is required.

• Technical: Technical knowledge and independent delivery of Dossier Due Diligence, Dossier Compilation, Quality Control, Submissions, Common Technical Documents and Local Technical Representative Liaising.

• System Orientated: Comfortable working across multiple systems and platforms, with a natural interest in technology and a willingness to learn, manage and maintain accurate information acrooss different tools.

Behavioural:

o Thinking: Analytical and rational thinking, creativity, strategic thinking, managing complexity, learning agile

o Relatability: Team player, maintaining relationships

o Delivering: Personal execution and delivery, quality orientated, focus and follow through, exact, maintaining the quality standard, goal focused, customer service orientation

o Personal: Energy and drive, adaptability, stress management, digital mindset, time management

Qualification Requirements

For the role, the following qualifications are required:

Tertiary qualification in pharmaceutical or health sciences field (B.Sc. or equivalent qualification)

Additional Information

Salary: Market Related, depending on experience and qualifications

Position Type: Fixed-term, Full-time

Work Location: Remote

Travel Requirements:

Frequency: By Exception

Type: Local travel

Reason for Vacancy: Additional workload

Contact Information

Please send your CV to [email protected] before or on Friday 4 Septembert 2026.