Senior Regulatory Affairs Consultant – EU Projects (Hybrid)

QbD Group; Polska; Hybride; PLN 349 000 - 481 000; Plein temps

Avantages offerts par ce poste

Private healthcare

Flexible benefits platform

Sports card

Lunch card

Group life insurance

Employee referral programme

Résumé du poste

QbD Group is seeking an experienced Regulatory Affairs professional to join a growing team delivering regulatory services across European markets. The role focuses on leading complex regulatory projects, coordinating submissions, and advising on lifecycle management in a collaborative, international consulting environment.

The ideal candidate will have 8+ years in Regulatory Affairs, strong knowledge of European procedures, and fluency in Polish or Spanish and English.

Qualifications

• University degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• Minimum 8 years of experience in Regulatory Affairs.
• Very good knowledge of European regulatory procedures and lifecycle management.
• Experience in managing complex regulatory projects.
• Fluent in Polish or Spanish and English, both spoken and written.
• Excellent communication and organizational skills, with the ability to set priorities.
• Independence, accountability, and strong problem-solving skills.
• Experience working with international clients and in a consulting environment would be an advantage.

Responsabilités

• Lead complex regulatory projects and provide advice on lifecycle management, national and European procedures.
• Coordinate the preparation, review, and submission of regulatory documentation.
• Support clients in resolving complex regulatory matters and responding to Health Authority queries.
• Ensure the high-quality and timely delivery of projects in line with regulatory requirements, scope, and budget.
• Collaborate with clients and internal teams to ensure the smooth delivery of projects.

Connaissances

Regulatory affairs

Project management

Regulatory procedures

Communication skills

Formation

University degree in Pharmacy or Life Sciences

Description du poste

QbD Group is seeking an experienced Regulatory Affairs professional to join a growing team delivering regulatory services across European markets. The role focuses on leading complex regulatory projects, coordinating submissions, and advising on lifecycle management in a collaborative, international consulting environment.

The ideal candidate will have 8+ years in Regulatory Affairs, strong knowledge of European procedures, and fluency in Polish or Spanish and English.