EU Regulatory Affairs Manager overseeing regulatory activities across assigned products in pharmaceuticals. Ensuring compliance and collaboration within a dynamic team environment in Farnborough.
About the role
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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