Regulatory Project Manager (Life Sciences)

Freyr Solutions; Poland; On-site; PLN 120,000 - 180,000; Full time

Job summary

Freyr Solutions is seeking a Regulatory Affairs Specialist (Project Management) located in Poland or Romania. The role focuses on independently managing submissions, co-leading global filings, and coordinating cross-functional teams to meet regulatory timelines.

Responsibilities include preparing agendas, facilitating kick-offs, tracking actions and decisions, and ensuring appropriate representation across functions for submissions.

Qualifications

• Independently leads regulatory submissions and supports global filings.
• Co-leads working groups with regulatory leads across markets.
• Develops and manages submission timelines with cross-functional teams.

Responsibilities

• Independently manages submissions and supports major global filings.
• Co-leads SWGs with regulatory leads for MAAs and supplements.
• Develops timelines based on data availability and critical path activities.
• Ensures cross-functional representation in submissions.
• Creates agendas and coordinates kick-off meetings with GRL/Reg Lead.
• Facilitates kick-off and presents timelines and SWG overviews.
• Collects inputs from team and prepares draft agendas.
• Keeps team on track and tracks action items and decisions.

Skills

Regulatory affairs

Project management

Cross-functional collaboration

Timeline management

Tools

InterACT

RPP

Job description

Freyr Solutions is seeking a Regulatory Affairs Specialist (Project Management) located in Poland or Romania. The role focuses on independently managing submissions, co-leading global filings, and coordinating cross-functional teams to meet regulatory timelines.

Responsibilities include preparing agendas, facilitating kick-offs, tracking actions and decisions, and ensuring appropriate representation across functions for submissions.