Posted on :
12 Nov, 2013
12 Nov, 2013
Bachelor of Science Degree and registration with the SAPC
A minimum of 2 years’ experience in a healthcare regulatory affairs environment
Regulatory Affairs Compliance experience
Pharmacovigilance training and experience
– CMC training/experience
– Risk Manager
– Training skills
Duties & Responsibilities
This individual is responsible to perform all activities pertaining to Chemistry Manufacturing and Controls (CMC) and regulatory affairs compliance aspects pertaining to Cipla SA.
You will be expected to liaise with internal departments and business units, associated companies (manufacturers, packers, laboratories and printers) and the strategic regulatory affairs team (Group Head: Regulatory Affairs, Responsible Pharmacists, Risk Committee, Quality Assurance and Regulatory Affairs Managers) on all aspects of CMC and Regulatory affairs compliance.
You will also be expected to serve in a key capacity for all Pharmacovigilance activities.
Responsibilities include ensuring continued adherence to regulations, auditing and monitoring of documentation, management of the life cycle of all product dossiers, pharmacovigilance, managing product complaints and supporting of and participating in the Corporate Compliance Program.
|Job Type Classification||Permanent|
|Equity Status||EE Preferred|
|Location – Country||South Africa|
|Location – Province||Western Cape|
|Location – Town / City||Bellville|
|Overview||CMC and Regulatory Affairs Compliance Pharmacist|