Senior Regulatory Affairs Consultant, Europe

QbD Group; Warszawa; Hybrid; PLN 393,000 - 524,000; Full time

Benefits offered by this job

Private healthcare

Flexible benefits platform

Lunch card

Group life insurance

Employee referral programme

Job summary

QbD Group is seeking an experienced Regulatory Affairs professional to lead multidisciplinary regulatory projects across European markets. You will advise on lifecycle management, manage submission processes, and work with Health Authorities and clients to deliver compliant solutions.

The role requires a university degree in Pharmacy or Life Sciences, 8+ years in Regulatory Affairs, and fluency in Polish or Spanish and English.

Qualifications

• Lead complex regulatory projects and advise on lifecycle management.
• Coordinate preparation, review and submission of regulatory docs.
• Support clients in resolving regulatory matters with Health Authorities.
• Strong communication and organizational skills required.

Responsibilities

• Lead complex regulatory projects and provide lifecycle management advice.
• Coordinate regulatory documentation preparation, review and submission.
• Support clients and respond to Health Authority queries.
• Ensure timely delivery within scope and budget.
• Collaborate with clients and internal teams for smooth delivery.

Skills

Regulatory project leadership

European regulatory procedures

Client communication

Project management

English language

Polish/Spanish bilingual

Education

University degree in Pharmacy / Life Sciences

Job description

QbD Group is seeking an experienced Regulatory Affairs professional to lead multidisciplinary regulatory projects across European markets. You will advise on lifecycle management, manage submission processes, and work with Health Authorities and clients to deliver compliant solutions.

The role requires a university degree in Pharmacy or Life Sciences, 8+ years in Regulatory Affairs, and fluency in Polish or Spanish and English.