Regulatory Affairs / Pharmacovigilance Pharmacist

Air Liquide; Gauteng; On-site; ZAR 400 000 - 600 000; Full time

Job summary

A leading industrial gases company based in Gauteng is seeking a Regulatory Affairs professional to manage compliance processes. Responsibilities include preparing SAHPRA dossiers, monitoring regulatory changes, and ensuring GxP compliance. Candidates should have a Bachelor of Pharmacy, be registered with the South African Pharmacy Council, and possess 3–5 years of relevant experience. Join a diverse team that fosters innovation in a dynamic environment.

Qualifications

• 3–5 years' experience in regulatory affairs, QA, or pharmacovigilance.
• Strong knowledge of SAHPRA, ISO, WHO GxP / GVP, GMP / GDP standards.

Responsibilities

• Develop, implement, and manage regulatory compliance processes.
• Prepare, submit, and maintain SAHPRA dossiers.
• Monitor regulatory changes and provide regulatory intelligence.
• Coordinate responses to authorities.

Skills

Regulatory Affairs knowledge

Pharmacovigilance expertise

Knowledge of SAHPRA

GxP compliance

Education

Bachelor of Pharmacy (BPharm) or equivalent

Registration with the South African Pharmacy Council

Job description

How will you CONTRIBUTE and GROW?

Provide assistance in order to develop, implement and / or manage the Industrial Regulatory compliance process within a specific scope in accordance with the group Procedure and / or corresponding Subsidiary's procedures (including : Healthcare Regulatory Affairs & Pharmacovigilance).

INCLUDE : jobs requiring a technical knowledge on the topicEXCLUDE : jobs requiring a pure legal expertise like a lawyer specialized in pharmaceutical law (they should be coded in the Job Family Legal & Intellectual Property, in the Group Job Regulatory Compliance Counsel)Regulatory AffairsPrepare, submit, and maintain SAHPRA dossiers.Monitor regulatory changes and provide regulatory intelligence.Support in inspections and audits.Coordinate responses to authorities.Maintain a registration database.PharmacovigilanceCollect, assess, and report adverse events.Maintain pharmacovigilance systems.Draft and maintain Risk Management Plans and PSUR's.Responsible for pharmacovigilance audits (Self inspection, ALLISA audit and external audit).

Communicate safety updates to stakeholders.Quality & ComplianceEnsure GxP compliance.Document control, deviation handling, CAPA.Provide training on regulatory / PV requirements.Collaborate with QA, production, and distribution teams.___________________Are you a MATCH?

• Bachelor of Pharmacy (BPharm) or equivalent.
• Registration with the South African Pharmacy Council.
• 3–5 years' experience in regulatory affairs, QA, or pharmacovigilance.
• Strong knowledge of SAHPRA, ISO, WHO GxP / GVP, GMP / GDP standards and regulations.

We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.