Regulatory Affairs Regional Dossier Publisher Position at MSD

A rare chance has emerged for experienced professionals seeking an MSD Regulatory Affairs Job. The organization is seeking a Regulatory Affairs Regional Dossier Publisher for its operations in Hyderabad, Telangana, and Prague, Czech Republic. This role is ideal for candidates with a strong background in regulatory publishing and dossier management.

About MSD

MSD is a global healthcare leader that develops innovative medicines and vaccines for some of the world’s most challenging diseases. With a commitment to improving health and well-being, MSD operates in various therapeutic areas, including oncology, infectious diseases, and vaccines. The company is dedicated to advancing healthcare through research and development, ensuring access to quality healthcare solutions worldwide.

Job Title: Regulatory Affairs – Regional Dossier Publisher

Location: Hyderabad, Telangana, India / Prague, Czech Republic

Experience Required: 4 years

Qualification: B.Pharm, M.Pharm, Pharm.D, B.Sc/M.Sc Life Sciences, Biotechnology, Pharmaceutical Sciences, or related disciplines

Published On: 04 September 2026

Job Details:

• Company: MSD
• Position: Regulatory Affairs – Regional Dossier Publisher
• Location: Hyderabad, Telangana, India / Prague, Czech Republic
• Experience: Minimum 4 years in regulatory submission publishing

MSD Regulatory Affairs Job Description

The Regional Dossier Publisher will serve as a regional subject matter expert for regulatory submission publishing. This MSD Regulatory Affairs Job involves supporting the assembly, publishing, validation, and delivery of dossiers to health authorities. Candidates should possess at least 4 years of regulatory publishing experience, including practical experience with Ennov Insight Publisher and/or Lorenz Docubridge, along with exposure to EU and EEMEA publishing requirements.

Key Responsibilities

• Serve as a regional subject matter expert for regulatory submission publishing.
• Support dossier structures, document formats, electronic submissions, and regulatory dossier repositories.
• Identify and apply regional and country-specific dossier formatting requirements.
• Assemble and deliver regulatory submissions to relevant health authorities.
• Support country Regulatory Affairs teams with local publishing and submission transmission requirements.
• Coordinate with central publishing teams to execute regulatory publishing processes.
• Conduct technical impact assessments for new or changing regulatory submission requirements.
• Mentor, coach, and manage external publishing resources when required.

Eligibility Criteria

• Minimum 4 years of experience in regulatory submission publishing.
• Hands-on experience with Ennov Insight Publisher and/or Lorenz Docubridge.
• Previous experience supporting EU and EEMEA regulatory publishing requirements.
• Knowledge of regulatory registration procedures applicable to the EU and EEMEA is considered an advantage.

Required Skills

• Proficient in regulatory submission publishing systems.
• Familiarity with electronic dossier and submission formats.
• Strong knowledge of document management systems.
• Proficient in Adobe Acrobat, Microsoft Office, and Microsoft Project.
• Excellent analytical and critical-thinking abilities.
• Strong attention to detail and organizational skills.
• Effective communication and customer-service skills.
• Ability to perform under tight submission deadlines.

Apply for the MSD Regulatory Affairs Job

Interested candidates can apply through the following link: CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE

Why Consider This MSD Regulatory Affairs Opportunity?

The Regional Dossier Publisher position offers a collaborative regulatory operations environment while supporting critical submission activities across EU and EEMEA markets. For professionals with relevant experience, this MSD Regulatory Affairs Job allows them to enhance their skills in regulatory publishing systems, dossier assembly, and submission delivery while contributing to the technical readiness of regional submission processes.

Note: The application deadline stated in the source notification may have passed. Verify before applying.

Conclusion

This position at MSD presents an excellent opportunity for qualified candidates to advance their careers in Regulatory Affairs. Interested professionals are encouraged to apply at the earliest to seize this opportunity.