Regulatory Publishing Specialist

Syneos Health
Full Time • Remote
₹5.5 Lakhs - ₹8 Lakhs
Gurugram, India
Posted 1h ago

Regulatory Publishing Specialist

Syneos Health

Job description

Looking to build a career in regulatory publishing? Explore this Regulatory Publishing Specialist role at Syneos Health in Gurugram.

 Company Description  

Syneos Health is a life sciences services organization that helps people succeed faster. Thw company works with innovators who create medicines from the early stages of drug development to the final steps of selling them. It deals with parts and moves projects forward quickly. Syneos Health has more than 25,000 employees. The company keeps shaping the future of healthcare by working being creative and following Syneos Health motto, Driven to Deliver.

 Job Summary  

This hybrid role is based in Gurugram or Hyderabad, focused on regulatory publishing for global submissions. As a Regulatory Publishing Specialist, you will perform assembler, publishing, and quality control tasks within electronic publishing systems. Your work will include preparing full application submissions, such as INDs, NDAs, and ANDAs. The role also involves troubleshooting eCTD builds and guiding entry level publishers.

 Key Responsibilities 

  • Perform assembler tasks, including creating publications and modifying outlines.

  • Add cross references and transform documents within the publishing system.

  • Apply publishing rules, prepare documents, and complete final publishing steps.

  • Perform quality control checks on published output and team prepared materials.

  • Create and assemble client deliverable documents using standard publishing tools.

  • Prepare full application submission builds for regulatory review.

  • Troubleshoot issues with eCTD builds and guide entry level publishers.

  • Review documents for legibility, completeness, and accuracy.

  • Log and track regulatory documents and related publishing materials.

  • Organize regulatory documentation, including pagination and cleanup tasks.

  • Receive and deliver client documents under close supervision.

  • Prepare and assemble applications such as INDs, NDAs, ANDAs, and DMFs for global submission.

 Educational Qualification 

  • BA or BS degree, with a preference for a science background.

 Skills Required 

  • 2 or more years of experience in regulatory publishing.

  • Experience in a regulatory environment, ideally within drug, device, or biologic industries.

  • Experience with electronic publishing of regulatory submissions is preferred.

  • Good working knowledge of MS Word, PowerPoint, and Excel.

  • Familiarity with tools like Extedo's eCTDManager, eSUBmanager, ISI Toolbox, ISI Publisher, eValidators, Acrobat, Veeva, or Documentum.

  • Knowledge of medical or scientific terminology, along with ICH guidelines.

  • Familiarity with submission requirements for markets like USFDA and EMA is a plus.

  • Good communication, organizational, and interpersonal skills.

  • Ability to work independently and follow detailed instructions.

  • Strong attention to detail and accuracy.

  • Ability to manage multiple projects with different requirements at once.

 Salary Structure 

A Regulatory Publishing Specialist at Syneos Health with 2 more years of experience brings the expected salary to approximately ₹5.5L to ₹8 L per year.

 Career Development  

This role offers hands on exposure to global regulatory publishing within a respected life sciences services organization. Syneos Health also supports long term growth through structured training, mentorship, and clear opportunities to advance across regulatory affairs roles.

 How to Apply  

  • Visit our job portal and search for the Regulatory Publishing Specialist role at Syneos Health.

  • Click on the job post to read all the details about the job.

  • Fill in your information. Upload your resume.

  • Submit your application.

Employment Type: Full Time • Remote
Industry: Healthcare
Role Category: Clinical Research
Application: External (Company Site)

Education

Bachelor's Degree

Key Skills

Clinical ResearchNon Clinical JobsMedical Affairs

Market insights & trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

Frequently Asked Questions

Everything you need to know about the process

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