Job Description

A leading pharmaceutical company is seeking a Regulatory Pharmacist to support the regulatory team to provide regulatory input to relevant departments within the company.

• Ensure compliant and timeous processing of regulatory submissions and commitments as assigned, including both Clinical and Quality Reviews.
• Responsible 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).
• Co-ordination, review, endorsement and submission of amendments for currently marketed products
• 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
• At least 1-2 yearsxe2x80x99 experience in Pharmaceutical Regulatory environment
• Computer literate with prior experience with MS Office, Regulatory Information Management System (DocuBridge Preferred) and Quality Management Systems.
• Attention to detail
• Understanding of the Regulatory requirements for pharmaceutical products
• 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