EU Regulatory Affairs Generalist (Remote)

Pharmavise Corporation; Poland; Remote; PLN 180,000 - 280,000; Full time

Job summary

Pharmavise Consulting Corp. is seeking an EU Generalist to lead regulatory affairs across the EU, guiding development, submission activities, and market access strategies.

This remote role requires strong collaboration with cross-functional teams to ensure EU compliance and successful regulatory outcomes. The ideal candidate holds a life sciences/regulatory degree with 5+ years of EU experience and prefers RAC-EU or TOPRA certification.

Qualifications

• Bachelor's degree in life sciences, pharmacy or regulatory affairs; advanced degree preferred.
• Minimum 5 years of EU regulatory affairs experience in pharma/biotech/medical devices.
• In-depth knowledge of EU regulatory requirements and centralized/decentralized procedures.
• Successful interactions with EU regulators, including submissions and meetings.
• Excellent communication and interpersonal skills to convey complex regulatory concepts.
• RAC-EU or TOPRA Diploma preferred but not required.

Responsibilities

• Serve as primary contact for EU regulations across functions.
• Monitor and interpret EU regs to ensure compliance and enable operations.
• Provide regulatory guidance for development, registration, and commercialization in EU.
• Coordinate regulatory submissions and interactions with EMA and national authorities.
• Stay updated on EU regulatory trends and train internal teams.

Skills

Regulatory affairs knowledge

Regulatory communication

Analytical problem solving

Independent & collaborative work

Education

Bachelor's in life sciences/pharmacy/regulatory affairs

Job description

Pharmavise Consulting Corp. is seeking an EU Generalist to lead regulatory affairs across the EU, guiding development, submission activities, and market access strategies.

This remote role requires strong collaboration with cross-functional teams to ensure EU compliance and successful regulatory outcomes. The ideal candidate holds a life sciences/regulatory degree with 5+ years of EU experience and prefers RAC-EU or TOPRA certification.