Regulatory Affairs Pharmacist

Job Description

Join our dynamic team as a Regulatory Affairs Pharmacist, where you will oversee the regulatory process for pharmaceutical products. The ideal candidate will have a strong understanding of regulatory requirements and a passion for compliance.

Responsibilities

• Oversee the preparation of registration dockets for new products.
• Evaluate clinical trial data for regulatory submissions.
• Assist in preparing responses to regulatory queries from health authorities.
• Ensure adherence to Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).
• Keep abreast of industry developments and changes in regulations.

Requirements

Education

• Bachelor's degree in Pharmacy
• Advanced Regulatory Affairs Certification preferred

Experience

• 3-5 years of experience in regulatory affairs

Technical Skills

• Pharmaceutical Regulations
• Project Management

Soft Skills

• Problem-solving
• Teamwork

Languages

• English: Fluent

Advantageous

• Experience with Clinical Trial Applications (CTAs): Knowledge and experience in preparing CTAs for submission.
• Understanding of International Health Regulations: Knowledge of global health regulations applicable to pharmaceuticals.

Benefits

• Comprehensive health and wellness program
• Flexible working hours with hybrid options
• Continuous learning and training programs
• Incentives for performance and achievements

Company Culture

• Team-Oriented Environment: We believe in collaboration and value input from all team members.
• Commitment to Excellence: Our focus is on quality and continual improvement in our processes.
• Ethical Practices: We uphold high ethical standards in all our operations.