Deputy Head of Regulatory - Johannesburg Verfied

Salary Negotiable Johannesburg, Gauteng Johannesburg, Gauteng more than 14 days ago 31-03-2014 1:40:53 PM
28-04-2014 1:40:53 PM
A well known pharmaceutical company based in Cape Town seeks a Deputy Head of Regulatory who will manage all aspects of the regulatory affairs department including staff mentorship.

Role:
Oversee and regulate the activities of regulatory pharmacists/ scientist with regard to new dossier compilation for South Africa and selected African countries.
Actively build relationship with MCC and equivalent bodies in SSA.
Provide guidance to overseas suppliers regarding product registration in South Africa
Support Head of Regulatory in managing existing dossier maintenance
Ensuring the approval of existing overseas manufacturing facilities and local suppliers in accordance with MCC requirements
Ensure continued development and maintenance of the EDMS (Electronic Document Management System)
Deputise and / or manage pharmacovigilence activities

Minimum Requirements:
B.Pharm
3-4 years working experience in Regulatory dossier submission
Pharmacovigilence experience
Exposure in dealing with international manufacturers
Knowledge of Marketing Code and CAMS guidelines
Established relationships with the MCC

Applicants who are willing to relocate to Cape Town will be considered.