Regulatory Affairs Publishing Specialist

Freyr Solutions; Poland; On-site; PLN 70,000 - 110,000; Full time

Job summary

Freyr Solutions is expanding its regulatory services in Warsaw, Poland, seeking a Regulatory Affairs Associate-Publishing. The role focuses on electronically preparing, publishing, validating, and dispatching regulatory submissions, across formats (eCTD, NeeS, Paper) and regions.

You will collaborate with a global team across the US, EU, and India, liaising with cross-functional stakeholders to ensure timely, HA-compliant submissions and continuous process improvement.

Qualifications

• BS in life sciences or a relevant discipline required.
• Experience with regulatory submission format, including familiarity with submission publishing activities and eCTD format criteria.
• Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
• Strong interpersonal, written and oral communication and presentation skills.
• Project management and time management skills to manage multiple ongoing projects.
• Ability to work independently with minimal supervision.
• Proficiency with computer programs (MS Office) and ability to learn new systems quickly.
• Analytical abilities and problem-solving skills.
• Ability to coordinate and work effectively with cross-functional teams.

Responsibilities

• Electronically prepare, publish, perform quality reviews, validate (eCTD validator) and dispatch regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, etc.).
• Produce HA-compliant submission outputs in eCTD, NeeS, and Paper formats in line with timelines and HA requirements (US, EU, LACan, Most World).
• Collaborate with Operations Submission Managers and a publishing team across US, EU, and India in a global capacity.
• Coordinate with cross-functional teams and document authors to ensure timely, high-quality submissions.
• Adhere to internal practices and guidelines and contribute to initiatives and training.
• Identify process or technical issues and propose timely solutions related to timing, quality, compliance and resources.
• Contribute to process efficiencies, documentation, and knowledge transfer within the RA team.

Skills

Regulatory submissions

eCTD publishing

Project management

Time management

Cross-functional collaboration

Effective communication

Problem solving

Independent work

MS Office

Analytical skills

Education

BS in life sciences

Tools

eCTD validator tool

Job description

Freyr Solutions is expanding its regulatory services in Warsaw, Poland, seeking a Regulatory Affairs Associate-Publishing. The role focuses on electronically preparing, publishing, validating, and dispatching regulatory submissions, across formats (eCTD, NeeS, Paper) and regions.

You will collaborate with a global team across the US, EU, and India, liaising with cross-functional stakeholders to ensure timely, HA-compliant submissions and continuous process improvement.