Analyst ensuring regulatory compliance for Medley's pharmaceutical products with ANVISA. Collaborating across teams to facilitate regulatory approvals and compliance within Brazil.
Responsibilities
Ensure compliance of Medley portfolio products with ANVISA
Manage registration processes, renewals, post-registration changes, and responses to regulatory inquiries
Collaborate with Quality, Pharmacovigilance, Operations, and the Campinas manufacturing site
Conduct competitive intelligence and monitor regulatory legislation
Review promotional materials to ensure regulatory compliance
Comply with and promote Sanofi's Health, Safety and Environment (HSE) policies
Support Sanofi's Diversity and Inclusion strategy and initiatives
Requirements
Prior experience in the pharmaceutical industry in Regulatory Affairs or related areas is desirable
Knowledge of Brazilian health regulatory legislation
Degree in Pharmacy, Biochemistry, Chemistry, or related fields
Intermediate to advanced English
Organized, flexible, proactive, able to work collaboratively, assertive communicator, intermediate MS Office skills
Benefits
Collaborative, dynamic work environment that values diverse perspectives and promotes continuous development
Results- and quality-oriented culture focused on making medicines accessible to the population
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