Regulatory Affairs Pharmacist

Forrester Pharma (Pty) Ltd; Cape Town; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A pharmaceutical company in Cape Town is seeking a Regulatory Affairs Pharmacist to manage eCTD submissions and comply with regulations. The ideal candidate will have active SAPC registration and relevant experience in product registration. Key responsibilities include liaising with manufacturers, conducting due diligence, and managing the lifecycle of generic medicines. This full-time position requires in-person attendance in Century City.

Qualifications

• Active registration with SAPC is mandatory.
• Experience in conducting due diligence and advising on product registration feasibility.
• Ability to manage generic medicines lifecycle.

Responsibilities

• Preparing and submitting eCTD dossier sequences.
• Liaising with manufacturers and laboratories for necessary information.
• Working as a team towards regulatory affairs goals.

Job description

Job Description

Regulatory Affairs Pharmacist. Active registration with SAPC is mandatory. SAHPRA experience: Must have personal, hands‑on experience in/ be knowledgeable on conducting due diligence (gap analysis) and advising on the feasibility of registration potential of a new product dossier. Preparing and submitting eCTD dossier sequences (including preparing country‑specific documents) as applicable to new applications for registration, quality and clinical variations, baselines, responses to queries, including associated tasks (e-CTD validation and fixing validation errors), liaising manufacturers, laboratories to obtain necessary information, etc. The responsibilities also include the requirements to register and manage the lifecycle of generic medicines and extension applications.

Experience with biological medicines will be an advantageous (new registrations and variations).

Knowledge on previously accepted dossier formats (like paper CTD, e-submission, MRF) will be advantageous. Experience with other regulatory authorities such as NMRC, ZAZIBONA, BoMRA etc. would be advantageous. Must be able to work in a team towards a common goal (i.e. RA department and company as a whole), but otherwise capable to run with a project in own personal capacity. Willing to act as a deputy RP will be an advantage. Must be based in Cape Town and have a reliable car to travel to/from work and be punctual (office based in Century City).

Job Types

Full-time, Permanent

Work Location: In person