Senior Regulatory Affairs Associate

Job Description:

• Experience with Maintenance regulatory applications in international markets or US and Canada
• Expertise in supporting CMC Major/ Minor Variations, Renewal and RTQs, M1 Authoring
• Knowledge of different tools such as Veeva Vault, Veeva RIM, etc
• May serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects
• Works within a team environment or individually based on the project needs
• Facilitates clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
• Works within broad project guidelines and facilitates issue and conflict resolutions

Education:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline