Regulatory Affairs Associate — Hybrid, Warsaw (Secondment)

AstraZeneca plc; Polska; Hybrid; PLN 120,000 - 180,000; Full time

Job summary

AstraZeneca plc in Warsaw is seeking a Regulatory Affairs Associate on a secondment/fixed-term contract through June 2027. The role supports licensing activities, document management, and regulatory submissions within a hybrid model (3+2).

You will liaise with Health Authorities, manage regulatory documentation, and collaborate with RAM to improve processes while mentoring teammates. English proficiency and project management experience are essential.

Qualifications

• Relevant qualification and/or experience in science.
• Experience in biopharmaceutical industry.
• Proficient English verbal and written.
• Project management skills.
• Experience in document management and tracking databases.

Responsibilities

• Document management and tracking of regulatory files.
• Plan, prepare and execute simple submissions.
• Interface with Health Authorities and regulatory systems.
• Order and track regulatory requirements (e.g., Certificates of Pharmaceutical Product, legal docs).
• Provide support across RAM for non-drug project roles.
• Coach and share knowledge within the RAM group.
• Contribute to process improvement.

Skills

English proficiency

Project management

Document management

Regulatory affairs knowledge

Team collaboration

Education

Science degree

Tools

Regulatory databases

Regulatory systems/tools

Job description

AstraZeneca plc in Warsaw is seeking a Regulatory Affairs Associate on a secondment/fixed-term contract through June 2027. The role supports licensing activities, document management, and regulatory submissions within a hybrid model (3+2).

You will liaise with Health Authorities, manage regulatory documentation, and collaborate with RAM to improve processes while mentoring teammates. English proficiency and project management experience are essential.