Requirements:
• Strong skills in Regulatory Documentation and Dossier Preparation for ROW markets.
• Knowledge of Regulatory Requirements and Regulatory Affairs processes for pharmaceutical products.
• Experience ensuring Regulatory Compliance in line with international and local guidelines.
• Degree in Pharmacy, Life Sciences, or a related field; advanced qualifications in Regulatory Affairs are an advantage.
• Attention to detail, solid organizational skills, and ability to manage multiple submissions and timelines.
• Effective written and verbal communication skills and ability to collaborate with cross-functional teams.
• Familiarity with generic pharma product development and quality systems is beneficial.
• Prior experience in regulatory affairs for ROW markets or similar regions is preferred.