My client is a multinational pharmaceutical company who seeks to employ a RA Pharmacist - Gauteng area


MINIMUM SKILLS/EXPERIENCE AND KNOWLEDGE REQUIRED (COMPETENCIES) :

• Tertiary Qualification [B Pharm] registered with SAPC or a Life Sciences degree
• A person with at least 4 -5 years regulatory experience.
• Submitted and had approval for registration dossiers in any of the SADC & ESA countries.
• Knowledge of relevant legislation in different SADC countries essential
• Good knowledge of the CTD sections

BRIEF DESCRIPTION OF KEY PERFORMANCE AEAS:

• To prepare applications, and the technical file according to local regulation, submit applications for registration and renewal, and receive approval for registration, and renewal according to the Company’s Business Plan.
• To participate to the annual Regulatory Plan (RAP) for the assigned countries
• To ensure that dossiers are maintained (through variations submission) and renewed on an ongoing basis.
• Follow-up of the RA activities in the assigned countries and report monthly to the Sub regional Head.
• Update the regulatory tools for the variation impact analysis as per the global directives.
• Review any new/updated local guideline, identify critical points, alert and propose action plan.
• Manage the entry and verification of data in the regulatory database according to the process.
• Support for the Health Authorities inspection’s preparation.
• To evaluate information against the regulatory requirements. To identify the deficiencies and pro-actively receive information to minimize regulatory risk.
• To ensure that promotional material complies with company and regulatory standards.
• To ensure that packaging material complies with the company and regulatory standards.
• To liaise with the health authorities on matters on regulatory importance.
• To foster a good working relationship with the Health Authority.
• To participate in Marketing and Production cross-functional teams &provide guidance to the unit on regulatory developments.