Regulatory Affairs Specialist

Job Description

Join our team as a Regulatory Affairs Specialist, where you will oversee and manage compliance with regulatory requirements for our healthcare-related products. You'll be instrumental in coordinating submissions for product approvals, liaising with local and international regulatory bodies, and ensuring that our products meet industry standards. Your contributions will be vital to our operational excellence and continuous improvement.

Responsibilities

• Conduct thorough evaluations of all regulatory documents.
• Coordinate with international teams for global product submission.
• Serve as a resource for product-specific regulatory information.
• Assist with the development of regulatory policies and procedures.
• Compile and submit responses to regulatory inquiries and requests.
• Track and report on industry trends in regulations and compliance.
• Evaluate the impact of regulatory changes on the product pipeline.
• Support product labeling and promotional initiatives ensuring they meet standards.
• Develop partnership with external regulatory bodies and stakeholders.

Requirements

Education

• Bachelor's degree in Life Sciences, Pharmacy, or related field
• Master's degree is advantageous

Experience

• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or healthcare industry.

Technical Skills

• Regulatory Compliance
• Project Management
• Analytical Skills

Soft Skills

• Attention to Detail
• Communication
• Teamwork

Certifications

• Certified Regulatory Affairs Professional (RAC)

Languages

• English: Fluent

Advantageous

• Understanding of Quality Management Systems: Knowledge of QMS and its importance in regulatory compliance.
• Project Leadership Experience: Experience leading cross-functional projects with significant regulatory impact.

Benefits

• Comprehensive health insurance plans
• Annual leave and sick leave provisions
• Educational reimbursement for further studies
• Opportunities for career advancement

Company Culture

• Focus on Quality: We are dedicated to maintaining high standards and delivering quality results for our clients.
• Community Engagement: We actively participate in community initiatives and support local outreach programs.
• Innovation-Driven: Encouraging innovative thinking is key to our success in the regulatory landscape.