MSD is hiring an experienced Regional Dossier Publisher for its Regulatory Affairs team. The position is available in Hyderabad, Telangana, India and Prague, Czech Republic, with a hybrid work arrangement.
The selected candidate will work as a regional subject matter expert for regulatory submission publishing, supporting dossier assembly, electronic submissions, submission transmission, regulatory publishing systems and country-specific requirements across the EU and EEMEA regions.
This role involves close collaboration with country Regulatory Affairs teams, central publishing teams and regulatory stakeholders to ensure accurate and timely delivery of regulatory submissions.
Key Responsibilities
- Act as a regional subject matter expert for regulatory submission publishing, including dossier structures, file formats, electronic submissions, transmission gateways and dossier repositories.
- Identify, maintain and implement dossier format requirements for assembling and delivering regulatory submissions to health authorities and country organizations.
- Support country Regulatory Affairs teams with local publishing and submission transmission requirements.
- Help ensure regulatory submissions are delivered within critical submission deadlines.
- Collaborate with central publishing teams to maintain and execute publishing processes according to regional and country-specific requirements.
- Promote standardization and consistency in regulatory publishing practices across supported countries.
- Lead technical impact assessments related to regional and country-specific regulatory submission requirements.
- Provide technical guidance and training to Regulatory Affairs teams regarding publishing processes and tools.
- Serve as a technical point of contact for health authorities and regulatory stakeholders within the region.
- Support the maintenance and validation of processes and systems used for regulatory submission assembly and delivery.
- Perform regulatory publishing activities according to key submission timelines.
- Participate in process improvement projects, system testing, readiness activities and performance measurement initiatives.
- Support technical validation activities related to regulatory publishing systems and processes.
- Mentor, coach and manage external publishing resources whenever required.
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Required Experience
Candidates applying for the Regional Dossier Publisher position should have:
- Minimum 4 years of experience in regulatory submission publishing.
- Hands-on experience with Ennov Insight Publisher and/or Lorenz Docubridge.
- Experience supporting EU and EEMEA regulatory publishing requirements is required.
- Knowledge of regulatory registration procedures in the EU and EEMEA regions will be an added advantage.
- Experience with dossier assembly, electronic submission formats and submission transmission tools.
Technical Skills
Candidates should have knowledge or experience with:
- MS Office applications
- Adobe Acrobat
- MS Project
- Document Management Systems
- Regulatory Publishing Systems
- Dossier Assembly
- Electronic Submission Formats
- Submission Transmission Tools
- Technical Applications and Publishing Platforms
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Core Competencies
The ideal candidate should demonstrate:
- Strong analytical and problem-solving skills
- Excellent attention to detail
- Strong customer service skills
- Excellent written and verbal communication
- Ability to work with stakeholders at different organizational levels
- Effective cross-functional collaboration
- Ability to work under pressure
- Ability to meet tight regulatory submission deadlines
- Strong organizational skills
- Proactive and solution-oriented approach
- Critical thinking and adaptability
- Project management and process improvement skills
Role Highlights
The Regional Dossier Publisher role provides an opportunity to work in a collaborative Regulatory Operations environment and support important regulatory submission activities across EU and EEMEA markets.
The selected candidate will gain exposure to a wide range of regulatory publishing processes, systems and improvement initiatives while contributing to standardization, technical readiness and continuous improvement.
The role also includes opportunities to support, train and mentor colleagues and external publishing resources.
Job Details
| Particulars | Details |
|---|---|
| Job Title | Regulatory Affairs – Regional Dossier Publisher |
| Company | MSD |
| Department | Regulatory Affairs / Regulatory Operations |
| Job Location | Hyderabad, Telangana, India / Prague, Czech Republic |
| Work Arrangement | Hybrid |
| Job Type | Full Time |
| Experience | Minimum 4 Years |
| Employment Status | Regular |
| Job Requisition ID | R415277 |
| Relocation | Not Available |
| Visa Sponsorship | Not Available |
| Travel | No Travel Required |
| Shift | Not Indicated |
| Driving License | Not Required |
| Hazardous Materials | N/A |
| Application Deadline | 1 October 2026 |
Location
Hyderabad, Telangana, India
The position is available at the MSD location in Hyderabad, Telangana, India, with a hybrid working arrangement.
Prague, Czech Republic
The role is also listed for Central Bohemian – Prague (Five), Czech Republic, under the same job requisition.
Who Can Apply?
This position is suitable for experienced professionals working in:
- Regulatory Affairs
- Regulatory Operations
- Regulatory Submission Publishing
- Pharmaceutical Regulatory Affairs
- Dossier Publishing
- Regulatory Documentation
- Electronic Regulatory Submissions
- Drug Regulatory Affairs
Candidates with hands-on experience in Ennov Insight Publisher or Lorenz Docubridge and EU/EEMEA regulatory publishing requirements are particularly relevant for this position.
How to Apply
Eligible and interested candidates can apply online through the official MSD careers portal. Candidates should review the complete job requirements and submit their application before the specified deadline.
Application Deadline: 1 October 2026
Please note that the job posting is effective until 11:59:59 PM on the day before the listed job posting end date. Candidates are therefore advised to complete their application no later than the day before the stated closing date.
Regulatory Affairs Regional Dossier Publisher Recruitment 2026 – FAQs
What is the qualification required for the Regional Dossier Publisher job?
The provided job description does not specify a particular educational qualification. Relevant experience in regulatory submission publishing and regulatory operations is the key requirement.
How much experience is required?
A minimum of 4 years of experience in regulatory submission publishing is required.
Is Ennov Insight Publisher experience required?
Hands-on experience with Ennov Insight Publisher and/or Lorenz Docubridge is required for the position.
Is EU and EEMEA experience required?
Yes. Experience supporting EU and EEMEA regulatory publishing requirements is specifically required.
Where is this job available?
The position is listed in Hyderabad, Telangana, India, as well as Prague, Czech Republic.
Is the job remote?
The position offers a hybrid work arrangement, rather than being fully remote.
Is relocation available?
No. The job posting states that relocation is not available.
Is visa sponsorship available?
No. The job posting states Visa Sponsorship: No.
Is travel required?
No. The position states No Travel Required.
What is the last date to apply?
The listed job posting end date is 1 October 2026. Candidates should apply no later than the day before the posting end date.
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