Regulatory Affairs Associate-Publishing

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 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.

Join Our Team:

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr's new chapter in Warsaw, Poland. Together, we can shape the future of regulatory solutions.

Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

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.