Regulatory Affairs Specialist

Job Description

The role of Regulatory Affairs Specialist involves ensuring that our products comply with all relevant regulations and standards. You will play a critical part in preparing regulatory submissions, monitoring changes in regulations, and liaising with regulatory authorities.

Responsibilities

• Prepare and submit regulatory documents and reports to health authorities.
• Stay updated on regulatory changes and implement process improvements.
• Engage with regulatory agencies to facilitate timely approvals.
• Analyze and interpret data to ensure compliance with regulations.
• Assist in the preparation of responses to regulatory inquiries.
• Help maintain an effective regulatory documentation system.
• Provide regulatory insights to guide product development decisions.
• Participate in internal and external meetings on regulatory matters.

Requirements

Education

• Bachelor's degree in Science, Pharmacy, or a related field
• Postgraduate qualifications in Regulatory Affairs are advantageous

Experience

• 2-5 years of experience in regulatory affairs or a related field.

Technical Skills

• Regulatory Submission Preparation
• Regulatory Knowledge
• Analytical Skills

Soft Skills

• Attention to Detail
• Communication Skills
• Problem-Solving

Certifications

• Certified Regulatory Affairs Professional (RAC)
• Postgraduate Qualification in Regulatory Affairs

Languages

• English: Fluent

Advantageous

• Familiarity with quality management systems: Knowledge of ISO standards and quality assurance processes.
• Experience with product development lifecycle: Hands-on experience in navigating the product development lifecycle in compliance with regulations.

Benefits

• Competitive salary and performance bonuses
• Health, dental, and vision insurance
• Flexible working arrangements
• Professional development opportunities

Company Culture

• Teamwork: We emphasise teamwork and collaboration to achieve our goals.
• Continuous Learning: We foster a culture of continuous learning and encourage our employees to develop professionally.
• Diversity and Inclusion: We are committed to a diverse and inclusive workforce, welcoming individuals from all backgrounds.