Regulatory Affairs Specialist

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

• 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.

• 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)

• 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.

• 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.

• 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.

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