Regulatory Affairs Consultant

Description

• Manage lifecycle maintenance activities, including renewals, variations, and responses to deficiency letters
• Coordinate submission and management work in Veeva Vault
• Collaborate with various stakeholders, attending regular calls and meetings
• May serve as Project Lead for small-scale projects or Work Stream Lead on larger projects
• Ensure project team delivers high-quality work meeting client expectations and timelines
• Manage project financials and identify new business opportunities
• Deliver consulting services within your area of expertise
• Maintain professional interactions with clients and internal teams

Qualifications

• University degree in a life science discipline
• Solid regulatory experience in EU, other non-EU markets preferred
• Proficiency in Module 1 and 3 writing
• Strong organizational and prioritization skills
• Excellent communication and teamwork abilities
• Ability to work independently and under guidance of Project Leads or Technical SMEs
• Commitment to continuous learning and self-development
• Fluent in English, written and spoken