Regulatory Affairs Specialist / Scientist

About

An established local pharmaceutical company has an opportunity for a regulatory affairs Specialist / Scientist to join their team.

Ideally, you should have at least ONE year of regulatory affairs experience, ideally dossier compilation experience, as well as experience in maintaining existing life cycle dossiers.

NOTE: BEE requirement for this position - Indian, African, Coloured preferred

Duties & Responsibilities

Job functions may be influenced by your level of experience, but ideally...

• Assist with compilation of New Product Dossiers in eCTD format.
• Updates, variations, maintenance, conversions and post-reg amendments, change controls
• Knowledge of electronic document management systems e.g. docuBridge, Drug track, trackwise, etc. an advantage.
• Review and update RA documents e.g. PI/PIL, labels, artwork, adverts, responses to RA authorities, etc.
• Safety updates
• General assistance of the RA pharmacist team.

Desired Experience & Qualification

• BSc or similar qualification ptreferred
• A minimum of ONE full year of experience as a Regulatory Affairs Specialist or RA Scientist, with extensive exposure to new product registration and product life cycle management for human medicines in South Africa and SADC.
• Prior experience in new eCTD registration application, eCTD pre-registration responses and eCTD post-registration variation submissions preparation preferred.

Package & Remuneration

Salary is negotiable to attract the top candidates.

Salary will be influenced by qualifications, specific years and specific experience in RA skills.

A salary range of R40k to R60k ctc per month is envisaged for this role.

Plus a possible incentive/performance-based annual bonus.

Total annual package can be around R500k to R700k