- Solid 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, strong 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.