Regulatory Affairs Specialist

Job Description

As a Regulatory Affairs Specialist, you will be crucial to ensuring our products comply with all regulations and standards. This role requires a blend of technical knowledge and communication skills to navigate complex regulatory environments effectively. You will be collaborating closely with cross-functional teams to facilitate timely product approvals.

Responsibilities

• Ensure regulatory compliance for drug products from development to market.
• Communicate effectively with cross-functional teams to align on regulatory strategies.
• Provide training on regulatory changes and compliance requirements.
• Prepare for and assist during regulatory inspections and audits.

Requirements

Education

• Bachelor's degree in Life Sciences or related field
• Postgraduate qualification in Regulatory Affairs is advantageous

Experience

• At least 3 years in regulatory affairs, including hands-on experience with drug submissions

Technical Skills

• Regulatory Compliance
• Risk Assessment

Soft Skills

• Team Collaboration
• Strategic Thinking

Certifications

• Regulatory Affairs Certification (RAC)
• Certified Quality Engineer (CQE)

Languages

• English: Fluent

Advantageous

• Advanced analytical skills using statistical tools: Experience with statistical software to analyse regulatory data.
• Knowledge of global regulations and guidelines: Familiarity with regulations in different international markets.

Benefits

• Health and wellness programmes
• Annual leave and public holidays
• Employee assistance programme
• Continuous training and professional development
• Opportunity for career advancement

Company Culture

• Empowerment: We empower our employees to take initiative and make decisions in their roles.
• Respect and Inclusion: Emphasizing the importance of inclusivity and respect within our diverse workforce.