Posted on :
12 Nov, 2013
12 Nov, 2013
A Bachelor of Pharmacy Degree or a Bachelor of Science Degree.
A minimum of 8 years’ experience in a healthcare regulatory affairs environment.
CMC training and / or experience
Regulatory Affairs Compliance training and / or experience
Duties & Responsibilities
This individual is responsible for managing all Chemistry Manufacturing and Controls (CMC) and regulatory affairs compliance aspects pertaining to Cipla SA.
You will be expected to provide advice and support to 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 manage the company’s pharmacovigilance programme, product complaint process and to serve in a key capacity for all Risk Management activities.
Responsibilities include managing adherence to regulations, auditing and monitoring of documentation, management of the life cycle of all product dossiers, risk management, pharmacovigilance, product and document quality management 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 Manager|
Close Date: 2013/11/14