Job Description

A leading pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist.

Job purpose:
To Support the Regulatory Affairs team with electronic compilation, documentation control and publishing of dossiers and tracking Regulatory Activity. Ensure compliant and timeous processing of regulatory submissions and commitments as assigned. To ensure legal compliance with the relevant Medicine Regulatory Authorities (Country Specific where applicable), including the South African Health Products Regulatory Authority (SAHPRA) and South African Pharmacy Council (SAPC).

Key Responsibilities:

• Entry Level position to Support the Regulatory Affairs team with electronic compilation, documentation control and publishing of dossiers
• Tracking Regulatory Activity
• Internal training
• Assisting with internal product queries from relevant departments
• Effectively managing activity within Regulatory, QA and administrative systems
• Preparing, reviewing and adhering to Standard Operating Procedures and Regulatory Guidelines.

Requirements:

• Bachelor of Pharmacy
• Minimum 1 year Regulatory Affairs experience but significant QA experience in pharma environment
• Computer literate with prior experience with MS Office, Document Management System and / or Quality Management Systems.

Competencies:

• Attention to detail
• IT skills, document management skills
• Project management skills
• Good language skills
• Ability to prioritize and work to tight deadlines
• Systems approach
• Cross Functional skills: Ability to network, liaise and negotiate with others
• Ability to set standard and objectives and monitor progress
• Problem solving and decision-making skills

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.

MNA Recruitment