Regulatory Affairs Specialist

Vicore Health is a South Africa‑based health‑product consultancy that offers services in healthcare strategy, regulatory affairs, and quality assurance to help pharmaceutical manufacturers achieve end‑to‑end solutions with long‑term partnerships in technology, demand generation, and logistics.

The company has a full‑time, fixed‑term Regulatory Affairs Specialist position that can be done remotely.

The job purpose is a mid‑level role handling the technical side and deliverables of an exclusive client project.

Key responsibilities include:
- Preparing and submitting new or generic product applications and line extensions to national regulatory agencies to meet registration requirements.
- Keeping marketing authorisations and licenses compliant with local rules and making sure client regulatory processes and systems follow SOPs.
- Assisting with name‑patient and unregistered medicine submissions.
- Supporting regulatory intelligence research across existing and new markets and sharing findings with relevant stakeholders.
- Aligning regulatory approvals with product launch and distribution plans.
- Contributing to regulatory discussions and working closely with other departments.
- Using regulatory software efficiently and accurately.

Required competencies and skills:
- Minimum 2 years of regulatory affairs experience.
- Technical know‑how in dossier due diligence, dossier compilation, quality control, submissions, common technical documents, and local representative liaison.

Behavioural requirements:
- Thinking: analytical and rational reasoning, innovative ideas, strategic planning, ability to handle complex situations, and quick learning.
- Relatability: collaborative team member who nurtakes professional relationships.
- Delivering: personal performance focused on quality, meticulous execution, goal orientation, and customer‑service mindset, ensuring precise standards and follow‑through.
- Personal: energetic and driven, adaptable, skilled in stress handling, digitally savvy, and effective at time management.

- Qualification requirements:
A tertiary degree in pharmacy or health‑science disciplines (B.Sc. or equivalent) is needed for the position.

- Additional information:
- Salary: set according to market rates based on experience and qualifications.
- Position type: fixed‑term, full‑time employment.
- Work location: remote setup.
- Travel: occasional local trips are expected.
- Reason for vacancy: the role involves extra workload.

- Contact information:
Applicants should send their CV to HR@vicorehealth.com by Wednesday, 25 February 2025.