Global Pharmaceutical company requires a Regulatory Affairs Pharmacist to join their JHB based team.

Responsibilities include:
Managing the assigned portfolio of products to ensure regulatory compliance at all times.
Evaluation of the registration packages received from Global RA (GRA) / local partners for possible deficiencies.
Requests data that is not present in the registration packages received, but is needed to obtain registration.
Prepares the registration applications for submission.
Prepares the responses in a timeous manner.
Maintain existing product registrations in line with current legal and in-house requirements.
Requests data required to do the technical updates from all the relevant sources.
Prepares and submits technical updates based on the review of current data versus data contained in the registration application.
Prepares and submits package insert amendments based on revised Company Core Data Sheets received from GRA.
Prepares and submits technical amendments based on requests and data received from GRA / local partners.
Keeps abreast of new developments in legislation, guidelines and recommendations of the South African Health Authorities.
Attends meetings with respect to new developments in the Regulatory Affairs arena.
Liaises with the MCC and, where necessary, on new developments in the registration process.

Knowledge, Skills, Competencies and Experience Required:
Literacy in the following software packages: Microsoft Office.
Knowledge of current legislation governing product registration.
Knowledge of other legal requirements impacting the regulatory environment e.g. advertising, GMP etc.
Knowledge of pharmacology and therapeutics.
At least two years experience in Regulatory Affairs.
Exposure to the marketing of products in the pharmaceutical environment an advantage.
Business planning acumen and ability.
Good communicator and self motivated.
Excellent interpersonal skills.
Ability to work efficiently, individually and as part of a team.
High levels of integrity.
Good attention to detail.

Education :
Tertiary qualification in Pharmacy or equivalent qualification.
Tertiary courses in Medicine Registration and / or Advertising Medicines.

The package consists of a high basic salary, Medical Aid, Provident Fund and Car Allowance.