Regulatory Affairs Officer

Job Description

Join our Pretoria office as a Regulatory Affairs Officer, where you will oversee regulatory submissions and manage compliance matters. Your expertise will ensure our products meet local and international regulations, enhancing our commitment to safety and efficacy.

Responsibilities

• Ensure timely submission of regulatory applications and manage correspondence with authorities.
• Support the intellectual property team in matters related to product patents and trademarks.
• Monitor product performance and post-market surveillance to ensure ongoing compliance.
• Review and analyze scientific data to inform regulatory submissions.
• Develop and implement policies and procedures for regulatory compliance.
• Assist in product recalls and adverse event reporting as necessary.
• Communicate regulatory requirements and updates to the team.

Requirements

Education

• Bachelor's degree in Pharmacy or related field

Experience

• 5+ years experience in regulatory affairs in pharmaceuticals or biotechnology

Technical Skills

• Regulatory submissions
• Risk assessment

Soft Skills

• Problem-solving
• Team player

Certifications

• Regulatory Affairs Certification (RAC)

Languages

• English: Fluent
• Afrikaans: Conversational

Advantageous

• Experience in clinical trials: Previous experience in regulatory submission for clinical trials is a plus.
• Familiarity with environmental regulations: Knowledge of laws and regulations governing drug development and market approval.

Benefits

• Competitive salary and benefits package
• Health and wellness programs
• Career development opportunities
• Work-life balance initiatives

Company Culture

• Innovation: We encourage our team members to think creatively and embrace new ideas.
• Collaboration: We foster a collaborative work environment that values teamwork and mutual respect.
• Diversity: Our company is committed to diversity and inclusivity in the workplace.