Freyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Role Overview
Title : Regulatory Affairs Associate - Regulatory Operations - Publishing
Location : United Kingdom
Experience 2 to 5 years in Regulatory Affairs.
Proficiency in Chinese Language is mandatory for this role.
Description
Publishing Resources
- Produce regulatory publishing deliverables (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) in accordance with US and global requirements, using electronic publishing tools, and an EDMS system.
- Perform independent publishing QC on published output, complete appropriate checklists and/or provide assessments for the activities around the quality of document-level publishing and submission readiness of source documents for submission-level publishing.
- Act as a liaison while coordinating regulatory publishing activities with other multidisciplinary teams.
- Provide expertise on regulatory publishing and authoring activities.
- Provide support for preparation, submission, tracking, and archival of electronic and paper submissions.
- Assist with development of assigned regulatory operations work instructions.
- Perform User Acceptance Testing (UAT) for publishing tools, as required.
- Participate in new technology evaluation for regulatory publishing needs
- Stay abreast with updates for regulatory and/or industry standards.
- Overall knowledge of FDA/EMA/HC/SwissMedic/TGA/MHRA/MedSafe/NMPA regulations/guidance and industry standards for electronic and paper submissions.
- Strong background in regulatory operations, including formatting, publishing, submitting, life-cycling, and archiving sequences.
- Demonstrated performance in managing and producing time-intensive deliverables.
- Knowledge of Document Management Systems (Documentum-based is preferred) and publishing tools (e.g., Lorenz docuBridge, InSight Publisher, Lorenz eValidator, GlobalSubmit Validate, GlobalSubmit Review, and ISI Toolbox).
- Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint.
- Recent experience with NDAs / MAAs/ NDSs and document level publishing is essential
#J-18808-Ljbffr