Syneos Health is hiring a Regulatory Publishing Specialist for its Regulatory Publishing team in India. The position is listed for Gurugram/Hyderabad, with the job posting indicating Remote (Pre-Approved) work. Candidates with 2+ years of regulatory publishing experience and a BA/BS degree, preferably in Science, can apply.

The role focuses on eCTD publishing, regulatory submission preparation, document assembly, quality control, publishing systems, and regulatory documentation for submissions to global health authorities.

Syneos Health Regulatory Publishing Specialist – Job Details

About the Regulatory Publishing Specialist Role

The Regulatory Publishing Specialist will support the preparation, assembly, publishing, and quality control of regulatory submissions. The position involves working with electronic publishing systems and preparing submissions such as INDs, NDAs, ANDAs, DMFs, variations, renewals, and routine reports for global regulatory authorities.

Professionals in this role may also troubleshoot eCTD builds, support entry-level publishers, review regulatory documents, and coordinate documentation across multiple projects.

Key Responsibilities

The major responsibilities for the Syneos Health Regulatory Publishing Specialist include:

• Perform assembler activities within regulatory document publishing systems.
• Create publications and modify submission outlines.
• Assign and transform documents and add cross-references.
• Perform electronic publishing activities, including applying publishing rules and preparing submissions.
• Conduct QC of documents and published output.
• Prepare and assemble client deliverables and regulatory submissions.
• Support full application submission builds.
• Troubleshoot issues associated with eCTD builds.
• Provide guidance and assistance to entry-level publishers.
• Review documents for legibility, completeness, and accuracy.
• Log and track regulatory documents and publications.
• Organize and compile regulatory documentation.
• Perform pagination, document clean-up, and duplication activities.
• Prepare applications for global regulatory authorities.
• Work on submissions including INDs, NDAs, ANDAs, DMFs, variations, renewals, and routine reports.

Regulatory Publishing Skills Required

Candidates should have experience or familiarity with relevant regulatory publishing technologies and tools, including:

• Extedo eCTDManager
• Extedo eSUBmanager
• ISI Toolbox
• ISI Publisher
• eValidators
• Adobe Acrobat
• Veeva
• Documentum
• Microsoft Word
• Microsoft PowerPoint
• Microsoft Excel

Knowledge of electronic regulatory publishing and eCTD submission processes will be particularly relevant for this position.

Eligibility Criteria

Applicants should meet the following requirements:

• BA/BS degree, with preference for a Science-related degree.
• 2+ years of Regulatory Publishing experience.
• Experience in a regulatory environment is preferred.
• Experience related to drug, device, or biologics industries is advantageous.
• Experience with electronic publishing of regulatory submissions is preferred.
• Working knowledge of basic Microsoft Office applications.
• Knowledge of medical and scientific terminology.
• Familiarity with ICH guidelines and regulatory procedures.
• Knowledge of regulatory submission requirements for markets such as USFDA and EMA is an advantage.
• Strong communication and organizational skills.
• Ability to work independently and follow detailed instructions.
• Strong attention to detail and accuracy.
• Ability to manage multiple projects simultaneously.

Who Can Apply?

This opportunity can be relevant to professionals working in:

• Regulatory Publishing
• Regulatory Operations
• Regulatory Affairs
• eCTD Publishing
• Clinical Research
• Pharmaceutical Regulatory Submissions
• Drug Regulatory Documentation
• Life Sciences Regulatory Operations

Candidates with experience preparing regulatory submissions and working with electronic publishing systems may find their existing experience closely aligned with the responsibilities described in the vacancy.

About Syneos Health

Syneos Health is a life sciences services organization working across drug development and commercialization. Its Clinical Solutions teams support customers through clinical development and related services.

According to the company’s job posting, Syneos Health emphasizes career development, technical and therapeutic-area training, peer recognition, and an inclusive workplace culture.

How to Apply

Application Link