Regulatory Affairs Publisher Consultant

Job Title: Regulatory Affairs Publisher Consultant

Location: Remote

ClinChoice is searching for Regulatory Affairs Publisher Consultant 12 months Contract with possibility of extension to join one of our consumer product clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Position Summary

The Regulatory Affairs Publisher Consultant is responsible for the preparation, formatting, quality control, and electronic submission of regulatory documents to global health authorities. This role ensures that submissions comply with regulatory requirements and are delivered accurately and on time using electronic publishing systems.

Key Responsibilities

• Prepare, format, and publish regulatory submission documents in electronic Common Technical Document (eCTD) format.
• Compile, review, and quality check submission components to ensure accuracy, completeness, and compliance with regulatory guidelines.
• Coordinate submission timelines with Regulatory Affairs teams, project managers, and cross-functional stakeholders.
• Perform technical validation of submissions using publishing and validation tools.
• Submit regulatory dossiers to global regulatory authorities (e.g., FDA, EMA, Health Canada, etc.) through appropriate submission gateways.
• Maintain submission archives and ensure proper document management within regulatory information systems.
• Support lifecycle management activities such as amendments, supplements, variations, and renewals.
• Ensure adherence to internal SOPs, regulatory requirements, and industry standards.
• Troubleshoot publishing issues and provide technical support for regulatory submission processes.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• Typically, 2–5+ years of experience in regulatory publishing or regulatory operations.
• Experience with eCTD publishing and submission processes.

Required Skills

• Strong knowledge of eCTD structure and global regulatory submission requirements.
• Experience with publishing tools such as Lorenz docuBridge, Extedo eCTDmanager, GlobalSubmit, or similar systems.
• Familiarity with document management systems (Veeva, SharePoint, etc.).
• Strong attention to detail and document quality control skills.
• Ability to manage multiple submissions and meet tight regulatory deadlines.
• Excellent organizational and communication skills.

Preferred Qualifications

• Experience with global submissions (FDA, EMA, PMDA, Health Canada, etc.).
• Understanding of regulatory lifecycle management and submission tracking systems.
• Experience working in pharmaceutical, biotechnology, or CRO environments.

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Key words: regulatory affairs, Global Submissions