Senior Regulatory Affairs Pharmacist: Pain, Derma - Gauteng - Ananzi

Description

Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD)

This role is based in Midrand and requires a strong background in pharmacy with experience in regulatory affairs.

Key Responsibilities:

1. Manage work streams for and report on assigned products.
2. Handle internal product queries from relevant departments.
3. Address external product queries from the SAHPRA, other MRAs, and third-party stakeholders.
4. Establish regulatory priorities and allocate resources and workloads.

Requirements:

1. Bachelor's Degree in Pharmacy.
2. Diploma in Pharmacy and Registration with the South African Pharmacy Council.
3. 5+ years' experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.

Core Competencies:

1. Experience in using CTD software builder and compiling eCTD dossier applications.
2. IT skills including Microsoft Office.
3. Ability to prioritize and work to tight deadlines.

Personal Qualities:

• Must demonstrate responsibility, excellence, and collaboration and align with Company values.