Regulatory Affairs Associate – Publishing (Global)

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

Job summary

Freyr Solutions in Warsaw, Poland, seeks a Regulatory Affairs Associate-Publishing to manage electronic submissions and publishing for global regulatory programs. The role collaborates with cross-functional teams across regions to ensure HA-compliant outputs and timely dispatch of dossiers.

The candidate should have a life sciences background, experience with eCTD formats, and strong communication skills to coordinate with project management, clinical, CMC, and quality teams.

Qualifications

• BS in life sciences or relevant discipline with min 2 years of professional work experience in Pharma or related industry.
• Experience with regulatory submission format and eCTD format criteria.
• Familiar with FDA, ICH and EMA guidelines/directives.

Responsibilities

• Prepare, publish, quality review, validate (eCTD validator) and dispatch regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, HA AtoQs, Global Labeling, Annual Reports).
• Produce HA compliant outputs in eCTD, NeeS and Paper formats per timelines and HA requirements.
• Collaborate with Operations Submission Managers and global publishing teams (US, EU, India).
• Coordinate with cross-functional teams to ensure timely, high-quality submissions.
• Support adoption of new tools, processes and training within RA.

Skills

Regulatory submissions

eCTD format

Publishing

Quality reviews

Validation

Cross-functional

MS Office

Education

BS in life sciences

Job description

Freyr Solutions in Warsaw, Poland, seeks a Regulatory Affairs Associate-Publishing to manage electronic submissions and publishing for global regulatory programs. The role collaborates with cross-functional teams across regions to ensure HA-compliant outputs and timely dispatch of dossiers.

The candidate should have a life sciences background, experience with eCTD formats, and strong communication skills to coordinate with project management, clinical, CMC, and quality teams.