Regulatory Affairs Specialist

Job Description

We are seeking a keen Regulatory Affairs Specialist to join our vibrant team in Cape Town. The successful candidate will oversee the approval of medical products and ensure compliance with regulatory requirements. This role is vital for ensuring our products meet health and safety standards.

Responsibilities

• Ensure compliance with local, national, and international regulations.
• Develop and implement regulatory policies and procedures.
• Lead initiatives to improve regulatory processes.
• Assist with the training of staff on regulatory matters.
• Provide expert advice and recommendations to internal stakeholders.
• Maintain regulatory records and databases.
• Assist with the renewal of product licenses and registrations.

Requirements

Education

• Bachelor's degree in Biomedical Science, Pharmacy or related field
• Postgraduate qualification in Regulatory Affairs is preferred

Experience

• 4-6 years of experience in a regulatory role within the life sciences sector

Technical Skills

• Clinical Trial Knowledge
• Regulatory Submissions

Soft Skills

• Analytical Skills
• Collaboration

Certifications

• Regulatory Affairs Certification (RAC)

Languages

• English: Fluent

Advantageous

• Experience in international regulatory submission: Experience with submissions for multiple global markets.
• Knowledge of pharmacovigilance processes: In-depth understanding of drug safety regulations.

Benefits

• Health and wellness programs
• Educational assistance for further studies
• Flexible working hours
• Employee discounts on pharmaceutical products

Company Culture

• Diversity and Inclusion: We value diversity and are committed to creating an inclusive workplace.
• Support for Development: We provide ongoing training and development for all our employees.
• Health and Wellbeing: Employee health and wellbeing are a top priority, supported through various initiatives.