PHARMAFull-time
Senior Specialist Submission Management
By Admin · Regulatory Affairs
BANGALORE (IN)ONSITEPOSTED: 9/13/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCK GROUPPharmaceuticals / Life Sciences
ROLE OVERVIEW
Senior regulatory submission management specialist responsible for planning, compiling, publishing, quality-checking, and dispatching regulatory submissions while ensuring compliance, data integrity, and submission timelines.
ROLE DEFINITION & RESPONSIBILITIES
- •Plan, compile, and dispatch submissions to Health Authorities
- •create and maintain submission packages and Submission Content Plans
- •maintain regulatory records and track Health Authority questions in Veeva Vault RIM
- •coordinate with R&D functions to obtain submission-ready documents
- •publish, quality-check, validate, and submit eCTDs through supported gateways
- •oversee submission management and publishing vendors
- •resolve vendor issues and protect quality and timelines
- •act as eCTD and publishing subject-matter expert and Veeva Vault RIM power user.
Reporting Hierarchy: Reports within the Regulatory Affairs/submission management function and works closely with Regulatory Leads, License Managers, R&D stakeholders, Health Authorities, and external publishing vendors.
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Degree in Life Sciences, Medical, PharmD, or related discipline with minimum MSc or equivalent
- 9–10 years total pharmaceutical industry experience
- 3–6 years of submission management or publishing experience
- experience with eCTD, NeeS, and paper submission formats
- experience in competent authority, academia, or R&D environment
- excellent written and verbal communication skills.
PREFERRED QUALIFICATIONS
- •Higher degree such as PhD
- •education or qualification in Regulatory Affairs
- •advanced expertise in Veeva Vault RIM
- •experience with health authority submission gateways.
REQUIRED VERIFIED SKILLS
Regulatory submissions
eCTD
NeeS
regulatory publishing
Veeva Vault RIM
Submission Content Plans
Health Authority submissions
submission quality control
regulatory information management
vendor management
regulatory compliance
submission gateways
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Professional development, inclusive and flexible working culture, career advancement opportunities; additional benefits not specified in the posting.
Compensation is undisclosed in the posting; no salary range or bonus/equity details are provided.
ORGANIZATION CONTEXT & CULTURE
Merck Group is a global science and technology company operating across Healthcare, Life Science, and Electronics, with a Healthcare business focused on medicines, intelligent devices, and innovative technologies.
TEAM SIZE: Large multinational enterprise
INDUSTRY: Pharmaceuticals / Life Sciences
Culture: Curiosity, scientific innovation, inclusion, belonging, flexibility, collaboration, and continuous professional development are emphasized.
EXPECTED CAREER ROADMAP
Can progress toward Regulatory Affairs management, submission management leadership, global publishing leadership, or broader regulatory operations roles.
APPLICATION ADVISORY
Highlight 9–10 years of pharmaceutical experience and 3–6 years specifically in submission management/publishing. Emphasize eCTD/NeeS expertise, Veeva Vault RIM, Health Authority submissions, vendor oversight, quality checks, and regulatory compliance.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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