Ra and Qa Manager pharmacist - Cape Town Verfied

Salary Negotiable Cape Town, Western Cape Cape Town, Western Cape more than 14 days ago 11-08-2014 4:00:59 PM
08-09-2014 4:00:59 PM
Our client, a leading Pharmaceutical company, located within the Western Cape region is seeking to employ an experienced Regulatory Affairs and Quality Assurance Manager who is registered with the Pharmacy Council.

Requirements:
B.Pharm or equivalent degree
Must be registered with the SAPC
Must have an extensive knowledge of regulatory requirements, including ICH requirements and national requirement for SA
Have an understanding of current global, regional and national trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
Strong QMS knowledge and excellent ability to manage the QMS
Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities
Demonstrate the ability to act as primary contact with Regulatory Authorities
Ability to manage complex relationships with distributors and agencies with the required tenacity and flexibility of style
Must be capable of taking a leadership role in providing regulatory advice and in updating and preparing the company for changes in legislation in assigned territories
Salary is highly negotiable, depending on experience, current package, qualifications, relocation etc.