DDReg Pharma Opens Applications for Regulatory Publishing Specialist in Regulatory Affairs

DDReg Pharma, an international provider of life sciences solutions specializing in pharmacovigilance, quality services, and digital compliance platforms, has announced an opening for the position of Regulatory Publishing Specialist within its Drug Regulatory Affairs (DRA) department. The opening is targeted at experienced regulatory operations professionals capable of handling global electronic submissions across key health authorities.

Interested and eligible candidates are invited to submit their applications online before the deadline on October 10, 2026.

Role Overview & Key Responsibilities

The Regulatory Publishing Specialist will oversee the end-to-end publishing, technical validation, and lifecycle maintenance of regulatory dossiers.

eCTD Compilation & Publishing: Prepare, assemble, and publish initial market applications, supplements, variations, annual reports, renewals, and formal agency responses utilizing industry-standard tools like DocuBridge and Lorenz.
Validation & Technical Quality Control: Conduct rigorous technical validation checks with tools such as eValidator; correct errors related to document formatting, bookmarks, hyperlinks, metadata, and eCTD folder structures in accordance with FDA, EMA, and ICH requirements.
Submission Lifecycle Management: Execute complex lifecycle sequences, including amendments, replacements, and withdrawals, ensuring complete document traceability from compilation to archiving.
Cross-Functional Collaboration: Coordinate closely with internal stakeholders across CMC, Non-clinical, Clinical, Medical Writing, and Pharmacovigilance to align on delivery schedules, mitigate submission bottlenecks, and ensure readiness.
Archive & System Maintenance: Oversee controlled versioning, tracking, and documentation in Document Management Systems (DMS) and Regulatory Information Management Systems (RIMS) to maintain audit readiness.

Eligibility & Professional Requirements

Educational Background: Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Biological Sciences, or a related scientific discipline. Postgraduate degrees or professional certifications in Regulatory Affairs are preferred.
Work Experience: 3 to 8 years of hands-on experience focused specifically on Regulatory Operations or Regulatory Publishing within the Pharma, Healthcare, or Clinical Research sectors.
Tool & Technical Expertise: Demonstrated proficiency in eCTD software (DocuBridge, Lorenz), validation software (eValidator), PDF preparation, electronic document publishing workflows, and health authority submission portals.

Job Summary Table