Regulatory Affairs Specialist

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.

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.

Requirements

Education

• A Master's degree in a related field is advantageous

Experience

• 5+ years of experience in the pharmaceutical industry

Technical Skills

• Clinical Trials
• Software Proficiency

Soft Skills

• Problem-solving
• Leadership

Certifications

• Advanced Certificate in Regulatory Affairs

Languages

• 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.