Job Description

A global pharmaceutical company is seeking a Regulatory Pharmacist.
Report all adverse events and safety information as per company and relevant Regulatory processes and requirements.
Regulatory Affairs:

• Ensure that all regulatory activities performed are in compliance with all the relevant provisions of the Medicines and Related Substances Act 101 of 1965, and any other countries legislation where applicable.
• Understand and interpret SAHPRA legislation/regulations and Industry Codes of Conduct relating to Regulatory Affairs in South Africa and the Sub-Sahara Region in order to maintain compliance.
• Regulatory Intelligence: Keep track of new regulations in South Africa and Sub-Saharan Africa and communicate these to the team with a view of implementation.
• Assist the Innovation/New Business team with regulatory orientation of new products.
• Ensure that compilation and submission of new product dossiers and line extensions are done on time and to all the relevant Health Authorities, for the long-term growth and benefit of the business.
• Ensure that all responses to Health Authority queries/recommendations are prepared and submitted on time, and that regular follow up is done until final approval is received.
• Ensure that all variations to approved dossiers are prepared, submitted and followed up until approval is received.
• Ensure that all processes, standards, and protocols are followed in terms of obtaining dossiers and gathering supportive data from suppliers.
• Submission of Urgent Safety-Related Package insert Notifications/Clinical updates of Professional Information /Patient Information Leaflets to the SAHPRA Clinical committee.
• Drive a culture of effective collaboration between the Regulatory, Pharmacovigilance, Compliance and Quality Assurance teams for continued compliance and the benefit of the business

Artwork Compliance:

• Approval of artwork for products from a Regulatory perspective

Requirements:

• BPharm degree
• Registration with the South African Pharmacy Council
• Minimum 1-year Regulatory Affairs experience.
• Exposure to Complementary Medicines and Medical Device regulations is preferred.
• Docubridge experience is preferred.
• Good project management skills.
• Well-developed problem solving and analytical skills.
• Excellent written and verbal communication skills.
• Attention to detail.
• Well-developed interpersonal skills, negotiation skills and customer focus.
• Ability to work well in a team environment

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.