Regulatory Publishing Specialist

DELHI NCR (IN)REMOTEPOSTED: 9/24/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
Syneos Health

ROLE OVERVIEW

Support the preparation, publishing, quality control, and submission of regulatory applications for global health authorities. The role requires hands-on electronic publishing expertise, strong attention to detail, and the ability to manage multiple regulatory projects concurrently.

ROLE DEFINITION & RESPONSIBILITIES

  • •BA/BS degree, preferably in a science discipline
  • •2+ years of regulatory publishing experience or moderate experience in a regulatory environment
  • •Working knowledge of MS Word, PowerPoint, and Excel
  • •Ability to work independently and follow detailed instructions
  • •Strong attention to detail and accuracy
  • •Good communication, organizational, and interpersonal skills
Reporting Hierarchy: Syneos Health is a fully integrated life sciences services organization supporting customers across the drug development and commercialization continuum. Its Clinical Solutions teams combine clinical development expertise with customer-focused delivery.

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Experience in drug, device, or biologic-related regulatory environments
  • Experience with electronic publishing of regulatory submissions
  • Experience with Extedo eCTDManager and eSUBmanager, ISI Toolbox, ISI Publisher, eValidators, Acrobat, Veeva, or Documentum
  • Knowledge of medical and scientific terminology
  • Knowledge of ICH guidelines and regulatory procedures
  • Familiarity with USFDA, EMA, and other market submission requirements

PREFERRED QUALIFICATIONS

  • •Reports within the Regulatory Publishing/Clinical Solutions function
  • •Provides guidance to entry-level publishers and collaborates with client and project teams

REQUIRED VERIFIED SKILLS

MS Office
medical terminology
scientific terminology
regulatory document review
project coordination
client communication
troubleshooting
mentoring

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Career development and progression; supportive line management; technical and therapeutic area training; peer recognition; total rewards program
Emphasize 2+ years of regulatory publishing experience; highlight hands-on eCTD and electronic publishing experience; list relevant tools such as eCTDManager, eSUBmanager, ISI Publisher, Veeva, or Documentum; demonstrate experience with IND, NDA, ANDA, DMF, variation, renewal, or other submissions; showcase QC, troubleshooting, accuracy, and multi-project management skills; mention knowledge of ICH and major regulatory-market requirements.

ORGANIZATION CONTEXT & CULTURE

Life Sciences Services / Clinical Research

TEAM SIZE: Syneos Health describes a culture centered on collaboration, innovation, inclusion, career development, challenging the status quo, and a purpose of being Driven to Deliver.
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: 2026-11-27

EXPECTED CAREER ROADMAP

The supplied job posting does not disclose a salary range, bonus, or equity information, so no compensation figures are provided.

APPLICATION ADVISORY

[https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram/Regulatory-Publishing-Specialist_25112836/apply

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.