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Pharmaceutical Regulatory Specialist

2 weeks ago

Johannesburg, Gauteng, South Africa Emporium Full time

About the Role

This is an exciting opportunity to join our team as a Pharmaceutical Regulatory Specialist. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with all relevant legislation and regulations related to pharmaceutical products.

Key Responsibilities:

  1. Compliance Management
  • Manage work streams for- and report on the assigned portfolio of products
  • Internal product queries from relevant departments
  • External product queries from regulatory authorities and stakeholders
Submission Preparation
  • Review regulatory agency submissions of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
  • Coordinate and submit new product applications in South Africa and other applicable territories
Strategy Development
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products
Quality Assurance
  • Conduct dossier due diligence to ensure all data gaps are addressed
  • Prepare registration applications for submission to regulatory authorities
Stakeholder Engagement
  • Work with internal and external stakeholders to assess regulator's submission requirements
  • Ensure maintenance and/or update of existing registrations in accordance with relevant legislation, regulations and guidelines
Regulatory Knowledge
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry

Requirements:

  • Experience in use of CTD software builder and compilation of eCTD dossier applications
  • IT skills including Microsoft Office
  • Ability to prioritise and work to tight deadlines
  • Systems and operations analysis
  • Basic cost management skills
  • Active learning
  • Strategic thinking
  • Ability to cope with a high degree of complexity and change
  • Cross Functional skills: Ability to network, liaise and negotiate with others
  • Ability to set standards and objectives and monitor progress
  • Complex problem solving and decision-making skills
  • Customer relationships
  • Development of people