Mindblowing Jobs

Regulatory Publishing Specialist

By Admin · Regulatory Affairs

DELHI NCR (IN)REMOTEPOSTED: 10/2/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
Syneos Health

ROLE OVERVIEW

Regulatory Publishing Specialist responsible for assembling, publishing and quality-checking electronic regulatory submissions and supporting full application submission builds for global regulatory authorities.

ROLE DEFINITION & RESPONSIBILITIES

  • •Perform document assembly tasks within electronic publishing systems
  • •Create publications, modify outlines, assign and transform documents, and add cross-references
  • •Perform electronic publishing, including special sheets, rules application, publishing preparation and final publishing
  • •Conduct QC of documents and published outputs
  • •Create, key and assemble regulatory deliverables and submission documents
  • •Prepare full application submission builds and troubleshoot eCTD build issues
  • •Provide guidance and assistance to entry-level publishers
  • •Prepare and assemble IND, NDA, ANDA, DMF, variation, renewal and routine regulatory submissions
Reporting Hierarchy: Reports within the Regulatory Publishing/Clinical Solutions function; provides assistance and guidance to entry-level publishers and collaborates with project and client teams

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

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • 2+ years of regulatory publishing experience
  • BA/BS degree, preferably in science, or equivalent relevant experience
  • Good working knowledge of MS Word, PowerPoint and Excel
  • Ability to work independently and follow detailed instructions
  • Strong communication, organizational and interpersonal skills
  • High attention to detail and accuracy

PREFERRED QUALIFICATIONS

  • •Experience in pharmaceutical, medical device or biologics regulatory environments
  • •Experience with electronic publishing of regulatory submissions
  • •Knowledge of medical/scientific terminology, ICH guidelines and regulatory procedures
  • •Knowledge of submission requirements for USFDA and EMA
  • •Experience with Extedo eCTDManager, eSUBmanager, ISI Toolbox, ISI Publisher, eValidators, Acrobat, Veeva or Documentum

REQUIRED VERIFIED SKILLS

Regulatory publishing
eCTD
regulatory submissions
document assembly
electronic publishing
submission QC
eCTDManager
eSUBmanager
ISI Toolbox
ISI Publisher
eValidators
Acrobat
Veeva
Documentum
MS Word
ICH guidelines
regulatory requirements

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Career development and progression, supportive line management, technical and therapeutic area training, peer recognition and total rewards program.
The posting does not disclose salary or bonus/equity information. Compensation should be confirmed directly with Syneos Health and may vary by experience, location and internal level.

ORGANIZATION CONTEXT & CULTURE

Syneos Health is a fully integrated life sciences services organization that supports customers across the drug development and commercialization continuum.

TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: Agile, collaborative and inclusive culture focused on customer success, innovation, professional development and the purpose of Driven to Deliver.

EXPECTED CAREER ROADMAP

Opportunity to progress toward Senior Regulatory Publishing Specialist, Regulatory Publishing Lead or broader Regulatory Operations roles, with potential specialization in eCTD publishing, submission management and global regulatory operations.

APPLICATION ADVISORY

Emphasize 2+ years of regulatory publishing experience; highlight hands-on eCTD submission assembly and publishing; list relevant systems such as eCTDManager, eSUBmanager, ISI Publisher, Veeva or Documentum; demonstrate QC and troubleshooting experience; mention exposure to IND, NDA, ANDA, DMF and global submissions; highlight accuracy and ability to manage multiple projects simultaneously.
RECOMMENDED TRAINING
1/5
Biologics Regulatory Affairs Certification

Biologics Regulatory Affairs Certification

READY TO SUBMIT?

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