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Regulatory Affairs Pharmacist

2 months ago

Midrand, Gauteng, South Africa Emporium Human Capital Full time
Key Responsibilities

Manage work streams, establish regulatory priorities, and allocate resources and workloads.

Review regulatory agency submission of materials to ensure timelines, accuracy, and compliance.

Coordinate and submit new product applications in South Africa and other applicable territories.

Develop regulatory strategies and implementation plans for the preparation and submission of new products.

Requirements

Bachelors Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council.

5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices.

Sound project management capabilities and ability to prioritize and work to tight deadlines.

Experience in use of CTD software builder and compilation of eCTD dossier applications.

IT skills including Microsoft Office and ability to network, liaise, and negotiate with others.

Personal Qualities

Ability to cope with a high degree of complexity and change. Must demonstrate responsibility, excellence, and collaboration.

Align with Company values and maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.

Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained.

Preferred Qualifications

Pharmaceutical production experience or exposure to supplement regulatory knowledge.

Active learning, strategic thinking, and complex problem-solving skills.

Development of people and customer relationships.

Core competencies including experience in use of CTD software builder and compilation of eCTD dossier applications.