Senior Regulatory Publishing Analyst

Regulatory Affairs Publishing AssociateThis role is ideal for a highly skilled and experienced Regulatory Affairs professional who has expertise in regulatory publishing, document management, and stakeholder engagement. As a Regulatory Affairs Publishing Associate, you will play a key role in supporting global regulatory submission activities by managing...

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Regulatory Operations Trainee on a permanent basis. You will work on projects from our varied client base,...

**Summary**: Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs) and provide publishing consultancy to the clinical teams and other line functions. **About the Role**: **Major accountabilities**: -...

Regulatory Publishing SpecialistEnsure compliance and quality of regulatory submissions by utilizing Veeva Vault eCTD Publishing to prepare and manage BLA submissions in eCTD format. Compile, format, and publish regulatory documents according to global health authority requirements.Key Responsibilities:Submission Preparation: Utilize Veeva Vault eCTD...

Associate III - Business Analysis Regulatory Affairs - Life Sciences Publishing Role Summary The Associate III - Business Analyst Regulatory Affairs - Publishing plays a crucial role in supporting regulatory operations within the life sciences industry This role involves understanding stakeholder needs gathering and analyzing requirements and...

**Key Responsibilities**: - Prepare, compile, and publish **Biologics License Application (BLA)**submissions in **eCTD format**using **Veeva Vault**and other publishing tools. - Format regulatory documents (PDFs) in compliance with **ICH and regional specifications**, including **bookmarks, hyperlinks, metadata**, and file naming conventions. - Perform...

Regulatory Affairs Senior AssociateWe are seeking a seasoned Regulatory Affairs professional to join our team as a Senior Associate. This role will involve assisting in the development and implementation of regulatory strategies across all product brands.Preparation, tracking, reporting, and archiving US regulatory documentationManagement of Ad Promo...

Job Title: Clinical Publishing SpecialistClinical publishing specialists play a vital role in ensuring the quality and compliance of clinical documents. As a member of our team, you will be responsible for compiling and adding electronic navigation to clinical and regulatory documents. Your attention to detail and ability to work independently will be...

Summary Ensure compliance with internal and external guidelines to compile and add electronic navigation to clinical and regulatory documents Support the timely submission of documents to the Health Authorities HAs and provide publishing consultancy to the clinical teams and other line functions Major accountabilities In collaboration with the clinical...