MSD Hiring Regulatory Affairs – Regional Dossier Publisher in Hyderabad | Regulatory Operations Careers
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(MSD Hiring Regulatory Affairs Regional Dossier Publisher) |
Introduction
MSD has announced an excellent career opportunity for experienced Regulatory Affairs and Regulatory Operations professionals. The company is hiring for the position of Regulatory Affairs – Regional Dossier Publisher, offering opportunities in Hyderabad, Telangana as well as Prague, Czech Republic.
This role is particularly suitable for candidates with experience in regulatory submission publishing, eCTD publishing, dossier management, electronic submissions, regulatory operations, document management systems, and submission lifecycle management. Professionals with expertise in Ennov Insight Publisher, Lorenz Docubridge, EU publishing requirements, and EEMEA regulatory submissions can find significant career growth through this opportunity.
If you are looking for Regulatory Affairs jobs in Hyderabad, Regulatory Publishing jobs, eCTD Publishing careers, or Regulatory Operations opportunities in the pharmaceutical industry, this MSD vacancy may be worth considering.
About MSD
MSD (Merck & Co., Inc., Rahway, NJ, USA) is one of the world's leading biopharmaceutical companies focused on discovering, developing, and delivering innovative medicines, vaccines, and healthcare solutions.
Founded in 1891, MSD operates across more than 140 countries and employs approximately 70,000+ professionals globally. The company has a strong presence in pharmaceuticals, vaccines, oncology, animal health, and research-driven healthcare innovations.
Company Information
- Company Name: MSD (Merck & Co., Inc.)
- Founded: 1891
- Headquarters: Rahway, New Jersey, United States
- Industry: Pharmaceuticals & Biopharmaceuticals
- Global Employees: 70,000+ Approx.
- Presence: 140+ Countries
MSD is recognized for maintaining high regulatory standards and supporting global regulatory submission activities across multiple markets.
Job Overview Summary
The Regulatory Affairs Regional Dossier Publisher will serve as a regional expert responsible for electronic dossier publishing, regulatory submissions, validation activities, and submission lifecycle management.
The role involves supporting country regulatory teams, preparing electronic submissions, ensuring compliance with regional requirements, and delivering regulatory dossiers to health authorities within defined timelines.
Professionals selected for this position will collaborate with Regulatory Affairs teams, publishing specialists, submission managers, and global stakeholders while supporting EU and EEMEA regulatory markets.
Vacancy Details
| Particulars |
Details |
| Company |
MSD |
| Position |
Regulatory Affairs – Regional Dossier Publisher |
| Department |
Regulatory Affairs / Regulatory Operations |
| Location |
Hyderabad, Telangana |
| Additional Location |
Prague, Czech Republic |
| Experience |
Minimum 4 Years |
| Industry |
Pharmaceutical / Biopharmaceutical |
| Employment Type |
Full-Time |
| Preferred Expertise |
eCTD Publishing, Dossier Publishing |
| Application Mode |
Online |
Job Role & Responsibility Explanation
The Regional Dossier Publisher plays an important role in ensuring that regulatory submissions are prepared and delivered accurately to health authorities.
Key responsibilities may include:
Regulatory Submission Publishing
- Preparing electronic regulatory submissions.
- Supporting eCTD dossier publishing activities.
- Managing submission lifecycle activities.
- Ensuring proper dossier structure and formatting.
Regulatory Documentation Management
- Reviewing submission-ready documents.
- Managing electronic document repositories.
- Supporting document version control processes.
Submission Validation
- Performing technical validation checks.
- Identifying publishing errors before submission.
- Ensuring compliance with regional submission standards.
Regulatory Operations Support
- Coordinating with country Regulatory Affairs teams.
- Supporting submission transmission activities.
- Assisting with local and regional publishing requirements.
Process Improvement Activities
- Supporting publishing system enhancements.
- Participating in testing and validation projects.
- Contributing to standardization initiatives.
Stakeholder Collaboration
- Working with internal Regulatory Affairs teams.
- Supporting external publishing partners.
- Providing technical guidance and publishing expertise.
Eligibility Criteria
Candidates interested in applying should meet the following requirements:
Educational Qualification
Commonly relevant educational backgrounds include:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
- Biotechnology
- Pharmaceutical Sciences
- Related Healthcare Disciplines
Experience
- Minimum 4 years of Regulatory Publishing experience.
- Experience in electronic regulatory submissions.
- Experience supporting regulatory operations activities.
Mandatory Technical Experience
- Ennov Insight Publisher
- Lorenz Docubridge
- Regulatory Submission Publishing
- eCTD Publishing
Preferred Regional Exposure
- EU Regulatory Publishing
- EEMEA Regulatory Publishing
Skills Required
Successful candidates may possess strong knowledge in:
- Regulatory Affairs
- Regulatory Operations
- Dossier Publishing
- eCTD Publishing
- Submission Lifecycle Management
- Regulatory Documentation
- Electronic Submissions
- Document Management Systems
- Ennov Insight Publisher
- Lorenz Docubridge
- Adobe Acrobat
- Microsoft Office
- Project Coordination
- Technical Validation
- Regulatory Compliance
Additional soft skills include:
- Attention to Detail
- Analytical Thinking
- Time Management
- Communication Skills
- Problem Solving
- Stakeholder Management
Estimated Salary
MSD has not officially disclosed compensation details.
Based on current pharmaceutical industry standards, professionals with 4+ years of Regulatory Publishing experience may expect:
Estimated Salary Range: ₹10 LPA – ₹22 LPA
Actual salary may vary depending on:
- Experience Level
- Publishing Expertise
- Technical Skills
- Previous Regulatory Operations Experience
- Company Compensation Policies
Interview Details
At the time of publishing this article, MSD has not announced any walk-in interview.
Expected Selection Process
- Online Application
- Resume Screening
- HR Discussion
- Technical Regulatory Publishing Interview
- Managerial Round
- Final Offer Discussion
Only shortlisted candidates are expected to be contacted.
Required Documents
Applicants should keep the following documents ready:
- Updated Resume/CV
- Educational Certificates
- Experience Certificates
- Latest Salary Documents
- Identity Proof
- Passport Size Photograph
- Regulatory Publishing Project Details
- Employment Verification Documents
- Skill Certifications (if available)
How to Apply
Interested and eligible candidates can apply through MSD's official career portal.
Application Method
Apply online through the official MSD recruitment platform.
Position:
Regulatory Affairs – Regional Dossier Publisher
Location:
Hyderabad, Telangana
Experience:
Minimum 4 Years
Frequently Asked Questions (FAQs)
Is this position suitable for freshers?
No. MSD requires a minimum of 4 years of regulatory publishing experience.
Is Hyderabad the only work location?
No. The role is available in Hyderabad, India and Prague, Czech Republic.
What publishing tools are required?
Candidates should have hands-on experience with Ennov Insight Publisher and/or Lorenz Docubridge.
Is eCTD publishing experience mandatory?
Regulatory submission publishing and eCTD exposure are highly preferred for this position.
Can B.Pharm candidates apply?
Yes. B.Pharm candidates with relevant regulatory publishing experience can apply.
What markets does this role support?
The position primarily supports EU and EEMEA regulatory publishing requirements.
Is Regulatory Operations experience important?
Yes. Regulatory Operations and submission management experience are highly valuable for this role.
Final Conclusion
The MSD Regulatory Affairs Regional Dossier Publisher position offers an excellent opportunity for experienced Regulatory Operations professionals looking to advance their careers in global pharmaceutical regulatory submissions.
Candidates with expertise in eCTD publishing, dossier management, submission lifecycle activities, Ennov Insight Publisher, Lorenz Docubridge, and EU/EEMEA regulatory requirements can benefit from working with one of the world's most respected pharmaceutical organizations.
For professionals seeking high-level Regulatory Affairs careers, Regulatory Publishing jobs, and international regulatory operations exposure, this MSD opportunity represents a strong career move.
Disclaimer
Note: Pharma Duniya does not charge any money for job information. Candidates are advised to verify details from the official company website.
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