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Regulatory Affairs Specialist

2 months ago

Johannesburg South, South Africa The Vine Partners Full time
Job Title: Pharmacist Regulatory Affairs

We are seeking a highly skilled Pharmacist Regulatory Affairs professional to join our team at The Vine Partners.

Key Responsibilities:
  • Regulatory Affairs Management: Manage work streams for- and report on the assigned portfolio of products, ensuring timely and accurate submissions to regulatory authorities.
  • Regulatory Strategy: Develop and implement regulatory strategies and implementation plans for the preparation and submission of new products, ensuring compliance with regulatory standards.
  • Regulatory Compliance: Ensure the maintenance and/or update of existing registrations in accordance with relevant legislation, regulations, and guidelines.
  • Stakeholder Management: Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders, and ensure alignment of personal and company values.
  • Regulatory Affairs Systems: Formulate or implement regulatory affairs systems, policies, and procedures to ensure regulatory compliance is maintained or enhanced.
Requirements:
  • Qualifications: Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council.
  • Experience: 3 to 5 years' experience in Regulatory Affairs, preferably in human medicines, with demonstrable experience across the product development, commercialization, and maintenance lifecycle.
  • Skills: Sound project management capabilities, proven ability to consistently deliver to quality, time, and cost standards, and experience in use of CTD software builder and compilation of eCTD applications.
What We Offer:

A competitive salary of R 67 000 and the opportunity to work with a dynamic team at The Vine Partners.