- Job Title Industrial Pharmacist & Regulatory Manager - Johannesburg
The Industrial Pharmacist and Regulatory Manager is accountable for the coordination and management of the product registration process for South Africa and export territories. The incumbent will manage the products life cycle including compilation of dossiers, while providing scientific, medical and technical support. They will act as a Deputy Responsible Pharmacist and a Local Backup Pharmacovigilance person in the efficient management of the pharmacovigilance (PV) process.
Responsible for compilation and submission of new product applications to the relevant Regulatory Authorities, ensuring that local registration requirements are fulfilled.
Responsible for the activities associated with the approval of a product including such activities as development, coordination and submission of responses to Regulatory Authority inquiries.
Monitor, follow up and report on progress of regulatory submissions and ensure registration, planning and tracking of regulatory database management.
Provide consultative support to product marketing teams on business decisions with regulatory implications.
Review promotional material to ensure that it is in compliance with company’s standards and that of the MCC and the Code of Marketing practice. Involved in the negotiation of first approval labelling with regulatory authorities, and labelling revisions over the product’s life cycle.
Provide world-class medical information (med info) within agreed timelines and release medical products onto the market.
REQUIRED EDUCATION & QUALIFICATIONS
B.Pharm degree registered with the SA Pharmacy Council
At least 3 years experience in Regulatory Affairs, Southern Africa, including conversions to CTD
At least 2 years in production or quality assurance
Knowledge and Know-how specific to the job
Knowledge of Acts, Regulations and Guidelines pertaining to the pharmaceutical industry
Knowledge of Medical information / pharmacovigilance
Knowledge of ISO 9001
Knowledge of Dossier compilation, including conversion to CTD
Send your CV to firstname.lastname@example.org
Successful applicants will be contacted within 2 weeks.