Regulatory Project Manager — Life Sciences Submissions

Freyr Solutions; Polska; On-site; PLN 180,000 - 240,000; Full time

Job summary

Freyr Solutions is seeking a Regulatory Affairs Specialist (Project Management) for Poland, Romania or UK locations. The role focuses on hands-on IND, BLA and NDA submissions with cross-functional team coordination in a dynamic, collaborative environment.

The candidate will manage submission timelines, coordinate SWGs, and ensure cross-functional representation across the project lifecycle to support global filings and regulatory strategies.

Qualifications

• Hands-on experience with regulatory submissions is required.
• Experience coordinating cross-functional teams for filings.

Responsibilities

• Independently manages submissions and supports RPM in managing major global filings.
• Co-leads SWGs with the regulatory lead for MAAs and supplements.
• Develops submission timelines with data availability and critical path activities.
• Ensures representation from needed cross-functional team members.
• Creates draft agendas and coordinates kick-off meetings with the team.

Skills

IND submissions

BLA submissions

NDA submissions

Cross-functional coordination

Job description

Freyr Solutions is seeking a Regulatory Affairs Specialist (Project Management) for Poland, Romania or UK locations. The role focuses on hands-on IND, BLA and NDA submissions with cross-functional team coordination in a dynamic, collaborative environment.

The candidate will manage submission timelines, coordinate SWGs, and ensure cross-functional representation across the project lifecycle to support global filings and regulatory strategies.