MSD (Merck Sharp & Dohme) is hiring for the position of Regulatory Affairs – Regional Dossier Publisher in Hyderabad, Telangana, and Prague, Czech Republic. This is a full-time, hybrid role focused on regulatory submission publishing, dossier assembly, electronic submission delivery, and technical support for regional Regulatory Affairs teams across the EU and EEMEA.
Candidates must have a minimum of four years of regulatory submission publishing experience, hands-on experience with Ennov Insight Publisher and/or Lorenz Docubridge, and experience supporting EU and EEMEA publishing requirements.
Job Details
| Particulars | Details |
|---|---|
| Company | MSD (Merck Sharp & Dohme) |
| Job Role | Regulatory Affairs – Regional Dossier Publisher |
| Job Requisition ID | R415277 |
| Job Locations | Hyderabad, Telangana, India; Prague, Czech Republic |
| Work Mode | Hybrid |
| Employment Type | Full-time, Regular |
| Experience Required | Minimum 4 years in regulatory submission publishing |
| Application Deadline | October 25, 2026, for timely submission |
| Relocation | Not provided |
| Visa Sponsorship | No |
| Travel | No travel required |
Positions
Regulatory Affairs – Regional Dossier Publisher
The role involves managing regulatory submission publishing activities, maintaining dossier format requirements, supporting electronic submissions, and coordinating with regional and country Regulatory Affairs teams to ensure timely submission delivery.
Key Responsibilities
- Serve as a regional subject matter expert in regulatory submission publishing, dossier structures, file formats, electronic submissions, transmission gateways, and dossier repositories.
- Maintain and apply dossier format requirements for regulatory submissions to health authorities and country organizations.
- Support country Regulatory Affairs teams with local publishing and submission transmission activities.
- Coordinate with central publishing teams to implement standardized publishing processes.
- Conduct technical impact assessments for regional and country regulatory requirements.
- Provide technical guidance and training on publishing processes and tools.
- Act as a technical contact for health and regulatory authorities in the region.
- Support the maintenance and validation of submission assembly and delivery systems.
- Perform regulatory publishing activities within submission timelines.
- Participate in system testing, technical validation, readiness activities, and process improvement projects.
- Mentor, coach, and manage external publishing resources as required.
Eligibility and Qualifications
Candidates applying for the MSD Regulatory Affairs – Regional Dossier Publisher job must meet the following requirements:
- Minimum 4 years of regulatory submission publishing experience.
- Hands-on experience with Ennov Insight Publisher and/or Lorenz Docubridge.
- Experience supporting EU and EEMEA publishing requirements.
- Knowledge of regulatory registration procedures in the EU and EEMEA is an added advantage.
Required Skills
Applicants should have experience or familiarity with the following technical tools and functional areas:
- Regulatory Publishing: Dossier assembly, electronic submission formats, submission transmission tools, and publishing systems.
- Publishing Software: Ennov Insight Publisher and/or Lorenz Docubridge.
- Technical Applications: MS Office, Adobe Acrobat, and MS Project.
- Document Management: Document Management Systems and regulatory documents.
- Regulatory Affairs: Pharmaceutical regulatory affairs, regulatory operations, regulatory compliance, and regulatory processes.
- Core Competencies: Analytical thinking, attention to detail, communication, stakeholder management, organization, adaptability, and working under tight deadlines.
- Additional Skills: Training, project management, performance improvement, and process improvement.
Application Details
