This is a fully remote position, open to applicants in Brazil.

📋 Description

• Assist the Regulatory Affairs teams (New Registrations and Portfolio) with the procedures for new product registrations and post-registration tasks, along with related documentation, ensuring adherence to current regulations concerning Active Pharmaceutical Ingredients (API).

• Analyze the Drug Master File (DMF) in accordance with the latest DIFA and CADIFA legislative frameworks, and evaluate the implications of DMF information in relation to new regulations, while considering the relevance of proposed new assumptions to routine operations.

• Oversee timelines, organization, and management of project information (including follow-ups with suppliers and internal colleagues).

⛳️ Requirements

• A degree in Pharmacy, Biochemistry, Chemistry, or related disciplines.

• Intermediate proficiency in English – both reading and writing.

• Proven experience in thorough DIFA analysis, evaluation of synthesis pathways for synthetic and semi-synthetic APIs, and impurity profiling.

• Experience in managing APIs within the portfolio and their precursors, from monitoring and evaluating changes made by manufacturers to developing internal strategies for post-registration regulatory updates in line with current regulations.