MSD is hiring for the position of Regulatory Affairs – Regional Dossier Publisher for its regulatory operations organization, with an opportunity available in Hyderabad, Telangana as well as Prague, Czech Republic.
This opportunity is particularly relevant for experienced professionals working in Regulatory Affairs, Regulatory Operations, dossier publishing, electronic regulatory submissions, eCTD publishing, document management, and submission lifecycle management.
The Regional Dossier Publisher will serve as a regional subject matter expert for regulatory submission publishing and support the assembly, publishing, validation, and delivery of dossiers to health authorities.
Candidates should have at least 4 years of regulatory publishing experience, including practical experience with Ennov Insight Publisher and/or Lorenz Docubridge and exposure to EU and EEMEA publishing requirements.
Key Responsibilities
As a Regional Dossier Publisher at MSD, the selected professional will:
- Serve as a regional subject matter expert for regulatory submission publishing.
- Support dossier structures, document formats, electronic submissions, transmission gateways, and regulatory dossier repositories.
- Identify and apply regional and country-specific dossier formatting requirements.
- Assemble and deliver regulatory submissions to relevant health authorities and country organizations.
- Support country Regulatory Affairs teams with local publishing and submission transmission requirements.
- Coordinate with central publishing teams to execute regulatory publishing processes.
- Promote standardized publishing practices across supported countries.
- Conduct technical impact assessments for new or changing regulatory submission requirements.
- Provide technical guidance and training to Regulatory Affairs teams.
- Act as a technical contact for regional health and regulatory authorities.
- Support maintenance and validation of submission publishing processes and systems.
- Perform hands-on regulatory publishing activities to meet submission deadlines.
- Participate in process improvement, system testing, readiness, and performance measurement initiatives.
- Support technical validation activities.
- Mentor, coach, and manage external publishing resources when required.
Qualification and Experience
The job description primarily specifies professional experience and technical competencies rather than a particular mandatory academic degree.
Candidates should have:
Experience: Minimum 4 years of experience in regulatory submission publishing.
Publishing Tools: Hands-on experience with Ennov Insight Publisher and/or Lorenz Docubridge.
Regional Experience: Previous experience supporting EU and EEMEA regulatory publishing requirements is required.
Knowledge of regulatory registration procedures applicable to the EU and EEMEA is considered an advantage.
For candidates from the pharmaceutical and life-sciences sector, relevant educational backgrounds commonly associated with Regulatory Affairs may include B.Pharm, M.Pharm, Pharm.D, B.Sc/M.Sc Life Sciences, Biotechnology, Pharmaceutical Sciences, or related disciplines. However, these degrees are not stated as mandatory qualifications in the supplied MSD job description.
Technical Skills Required
Candidates should be comfortable working with:
- Ennov Insight Publisher
- Lorenz Docubridge
- Regulatory submission publishing systems
- Electronic dossier and submission formats
- Document Management Systems
- Adobe Acrobat
- Microsoft Office
- Microsoft Project
- Submission transmission tools and gateways
- Regulatory dossier repositories
- Technical applications supporting regulatory operations
Knowledge of regulatory documents, regulatory compliance, regulatory processes, document management, regulatory operations, project management, and pharmaceutical Regulatory Affairs will be valuable for this position.
Core Competencies
MSD is looking for candidates with strong:
- Analytical and critical-thinking abilities
- Attention to detail
- Communication and customer-service skills
- Stakeholder management capabilities
- Organizational and time-management skills
- Ability to perform under tight submission deadlines
- Proactive problem-solving mindset
- Cross-functional collaboration skills
Why Consider This MSD Regulatory Affairs Opportunity?
The Regional Dossier Publisher position provides an opportunity to work in a collaborative regulatory operations environment while supporting important submission activities across EU and EEMEA markets.
The role provides exposure to regulatory publishing systems, dossier assembly, submission delivery, technical validation, process standardization, system testing, and continuous improvement initiatives.
Professionals can also contribute by training colleagues, supporting Regulatory Affairs teams, mentoring external publishing resources, and improving the technical readiness of regional submission processes.
Who Should Apply?
This position is best suited to experienced Regulatory Affairs and Regulatory Operations professionals, rather than freshers.
You may be a strong candidate if you have:
- 4+ years of regulatory publishing experience
- Hands-on Ennov Insight Publisher or Lorenz Docubridge experience
- EU/EEMEA regulatory publishing exposure
- Experience assembling and delivering electronic regulatory dossiers
- Experience with regulatory submission systems and document management
- Strong understanding of dossier formats and publishing requirements
Professionals currently working as Regulatory Publishing Specialists, Dossier Publishers, Regulatory Operations Specialists, Regulatory Submission Publishers, Regulatory Affairs Specialists, or Regulatory Operations Associates may find this opportunity particularly relevant.
How to Apply
