Regulatory and Clinical Affairs Manager

SUMMARY:
Regulatory and Clinical Affairs Manager

POSITION INFO:

REGULATORY AND CLINICAL AFFAIRS MANAGER (DURBAN)

Department: Regulatory and Clinical Affairs

Minimum Requirements

• B. Pharm degree
• M.Sc. Clinical Pharmacy or equivalent postgraduate degree
• Registered with the South Africa Pharmacy Council (SAPC)
• 5 years’ experience in the SA pharmaceutical regulatory environment
• 3 years’ experience with Medicines Information Services
• A minimum of 3 years’ experience at senior management level including leading, mentoring and coaching teams.
• A thorough understanding of the requirements of a pharmaceutical quality system and cGMP principles.
• Fully proficient in MS Office (Word, Excel, PowerPoint, Outlook)
• Good working knowledge of bibliographic management software Fully proficient in databases such as MS Access, Lotus Notes, InforMED, PCV Manager or similar.
• Clinical Trials Knowledge & Experience.
• SAP experience will be an added advantage.

Position reports to: Head of Division: Quality Management and Scientific Affairs

About the role

Directing and managing the Regulatory and Clinical Affairs (RCA) department to ensure provision of and adherence to best practices relating to regulatory compliance and clinical information with respect to the manufacture, sale and appropriate clinical use of safe, quality, efficacious products in accordance with registration commitments, operational and strategic requirements and internationally accepted regulatory standards and those accepted by the South African Health Products Regulatory Authority (SAHPRA) and other regulatory agencies.

Specific Operational Requirements

• Required to work an 8 hour day between 08h00 to 16h00
• The successful candidate may be required to work overtime to meet the business needs

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