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Job Description
We are searching for a meticulous Regulatory Affairs Specialist who will provide strategic regulatory guidance and ensure compliance with local and international regulations. The ideal candidate will have a strong background in regulatory affairs within the pharmaceutical industry.

Category: Legal and Compliance - Regulatory Affairs
Full-time
  • R500,000 - R1,500,000 / Year
  • R41667 - R125000 / Month

Closing Date: 2024-12-15
Location: Johannesburg
Job Responsibilities
  • Oversee the preparation of regulatory submissions and responses.
  • Ensure timely and accurate reporting of adverse events.
  • Collaborate with cross-functional teams to ensure compliance throughout the product lifecycle.
  • Maintain knowledge of changing regulations and standards.
  • Assist in the preparation of compliance training and educational resources.
  • Participate in internal audits to assess compliance.
  • Manage regulatory submissions to maintain product registrations.
  • Collaborate with legal teams to address compliance issues.
  • Lead projects to implement regulatory strategies.
  • Mentor junior staff on regulatory processes.
Job Requirements
  • A degree in Science, Pharmacy, or a related field
  • Regulatory Compliance Deep understanding of local and international regulations related to pharmaceuticals.
  • Document Preparation Proficient in preparing and reviewing regulatory submissions and documents.
  • Regulatory Knowledge Strong knowledge of GMP, GLP, and GDP regulations.
  • Analytical Skills Exceptional analytical skills for problem-solving in regulatory contexts.
  • Communication Strong verbal and written communication skills.
  • Team Collaboration Ability to work well with cross-functional teams.
  • Attention to Detail High level of attention to detail in all aspects of work.
  • Membership of a relevant professional body
  • Certification in Regulatory Affairs (RAC)
  • English (Fluent)
Advantageous
  • Experience with medical devices: Knowledge of regulatory requirements pertaining to medical devices.
  • Experience with emerging markets: Understanding market dynamics and regulatory requirements in emerging markets.
  • Experience with product registration processes: Familiarity with the product registration process in South Africa.
Benefits
  • Competitive salary ranging from R500,000 to R1,500,000 per annum.
  • Comprehensive health insurance plan.
  • Contributions towards a retirement fund.
  • Training and professional development opportunities.
  • Flexible work hours.
Company Culture
  • Collaboration and Inclusivity: We cultivate a collaborative working environment that values diverse perspectives and teamwork.
  • Continuous Learning and Innovation: We encourage ongoing learning and the sharing of new ideas within our team.
  • Integrity and Accountability: We uphold the highest standards of integrity and accountability in all our actions.
How to Apply
  • Once you have logged in and completed your profile, simply click "Apply Now" to add your application for the Regulatory Affairs Specialist position and share your profile with the recruiter.
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