Hybrid Regulatory Affairs Lead – Submissions & Strategy

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

Job summary

AstraZeneca plc in Warsaw, Poland, is hiring a Regulatory Affairs Manager on a fixed-term contract (through June 2027). The role leads end-to-end regulatory planning, submission strategy, and cross-functional coordination to ensure timely product registrations across regions in a hybrid work model (3 days in the office per week).

You will drive submission plans, review documentation, identify risks, and mentor RAM colleagues while collaborating with GRO, MCs, CROs and alliance partners to meet

Qualifications

• University degree in science or related discipline
• 4+ years regulatory experience in biopharma or health authority
• Strong project management and leadership skills
• Knowledge of drug development processes

Responsibilities

• Understand regulatory frameworks across regions for various applications
• Provide input on procedural and documentation requirements
• Lead submission planning and content for dossiers
• Review study protocols and other regulatory documents
• Develop and maintain submission delivery plans and status updates
• Coordinate input and revision in Planit project plans
• Identify regulatory risks and propose mitigations
• Support TMF and document management activities
• Coach and mentor RAM team members
• Contribute to process improvement

Skills

Project management

Leadership

Regulatory knowledge

Communication

Stakeholder management

Education

Relevant University Degree in Science

Tools

MS Project

Document management tools

Job description

AstraZeneca plc in Warsaw, Poland, is hiring a Regulatory Affairs Manager on a fixed-term contract (through June 2027). The role leads end-to-end regulatory planning, submission strategy, and cross-functional coordination to ensure timely product registrations across regions in a hybrid work model (3 days in the office per week).

You will drive submission plans, review documentation, identify risks, and mentor RAM colleagues while collaborating with GRO, MCs, CROs and alliance partners to meet