Senior Regulatory Affairs Analyst – DMF

Accountabilities:

• You will act as a technical expert in DIFA and CADIFA processes, providing strategic guidance and risk management.
• You will manage regulatory activities throughout the API lifecycle, from manufacturer qualification to post-registration changes.
• You will support internal teams with API evaluation and approval processes.

Requirements:

• You have a bachelor's degree in a scientific field such as Pharmacy, Biochemistry, or Chemistry.
• You possess advanced English proficiency and extensive experience with national and international API regulations.
• You have proven experience in DIFA/DMF documentation analysis and API manufacturer qualification.

Benefits:

• You will enjoy a fully remote work model based in Brazil with flexible working hours.
• You will receive comprehensive benefits including meal allowance, food allowance, and profit-sharing.
• You will have access to additional benefits: medical, dental, life insurance, pension plan, and fitness partnerships.