EU Regulatory Affairs Specialist

Job Summary

A company is looking for an EU Generalist.

Key Responsibilities

• Serve as a key contact for EU regulations and compliance across the organization
• Monitor and interpret EU regulations applicable to pharmaceutical, biotechnology, and medical device products
• Provide regulatory guidance for product development, registration, and commercialization activities in EU member states

Required Qualifications

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred
• Minimum of 5 years of experience in regulatory affairs focused on EU regulations
• Deep understanding of EU regulatory requirements for pharmaceutical, biotechnology, and medical device products
• Proven track record of successful interactions with EU regulatory authorities
• Regulatory affairs certification (RAC-EU) or relevant professional certification preferred but not required