Regulatory Affairs Associate - Biopharma Submissions Hybrid

AstraZeneca plc; Warszawa; Hybrid; PLN 180,000 - 240,000; Full time

Job summary

AstraZeneca plc in Warsaw is seeking a Regulatory Affairs Associate on a secondment/fix-term contract with a hybrid 3+2 model. You will assist in obtaining and maintaining licences, coordinate simple submissions, and serve as a main interface with Health Authorities under AZ standards.

The role emphasises document management, tracking, and collaboration with RAM teammates, while contributing to process improvements and knowledge sharing across regulatory teams.

Qualifications

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

Responsibilities

• Document management including uploading and tracking regulatory files per AZ procedures and regulatory requirements.
• Plan, prepare and execute simple submissions and assist with regulatory dispatches.
• Interface with Health Authorities and their systems for regulatory tasks (fees, FDA correspondence, EudraLink, HA portals).
• Order and track regulatory documents such as Certificates of Pharmaceutical Product and Letters of Authorisation.
• Provide support across RAM; act as contact point or superuser and coach team members.

Skills

English proficiency

Project management

Document management

Communication skills

Education

Science degree

Job description

AstraZeneca plc in Warsaw is seeking a Regulatory Affairs Associate on a secondment/fix-term contract with a hybrid 3+2 model. You will assist in obtaining and maintaining licences, coordinate simple submissions, and serve as a main interface with Health Authorities under AZ standards.

The role emphasises document management, tracking, and collaboration with RAM teammates, while contributing to process improvements and knowledge sharing across regulatory teams.