Regulatory Affairs Associate-Publishing

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 is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint to Warsaw, Poland, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Title : Regulatory Affairs Associate-Publishing

• Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool), and dispatch activities related to regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, HA AtoQs, Global Labeling, Annual Reports, etc.).
• Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements (US, EU, LACan, Most of World).
• Partners with Operations Submission Managers and a publishing team located in 3 regions (e.g., US, EU and India) and actively functions in a global capacity.
• Liaises /collaborates with cross functional team members and document authors (e.g., Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high quality submissions.
• Comply with and actively apply internal work practices and guidelines.
• Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts.
• Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources.
• Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team.

REQUIRED:

• BS in life sciences or a relevant discipline with min 2 years of professional work experience in Pharma or related industry.
• 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.
• Effective interpersonal skills, strong written and oral communication and presentation skills.
• Project management and time management skills to manage multiple ongoing projects simultaneously.
• Works independently and with minimal supervision.
• Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
• Analytical skills and problem solving skills.
• Ability to coordinate and work effectively with cross-functional teams.