PHARMAFull-time
Senior Specialist Submission Management
BANGALORE (IN)ONSITEPOSTED: 9/19/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCKScience and Technology; Pharmaceuticals and Life Science
ROLE OVERVIEW
Senior regulatory submission management role focused on planning, publishing, quality checking and dispatching regulatory submissions to Health Authorities.
ROLE DEFINITION & RESPONSIBILITIES
- •Plan, compile and dispatch regulatory submissions
- •create and update submission packages and Submission Content Plans
- •maintain regulatory records in Veeva Vault RIM
- •coordinate with R&D functions for submission documents
- •publish and quality-check eCTD outputs
- •submit eCTDs through supported Health Authority gateways
- •coordinate submission management and publishing vendors
- •resolve vendor issues and queries
- •provide eCTD and publishing expertise
- •author cover letters and application forms
- •monitor submission compliance
- •improve submission standards and templates.
Reporting Hierarchy: Specific reporting manager is not stated; role collaborates with Regulatory Leads, License Managers, R&D functions and submission management 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 submission management or publishing experience with eCTD, NeeS and paper formats
- experience in competent authority, academia or R&D environment
- excellent written and verbal communication skills
PREFERRED QUALIFICATIONS
- •Higher degree such as PhD
- •education in Regulatory Affairs
REQUIRED VERIFIED SKILLS
Regulatory submission management; eCTD publishing; NeeS; Veeva Vault RIM; regulatory information management; Health Authority submissions; quality control; submission standards; vendor management; compliance; communication
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Not specified in the posting
Salary is not disclosed in the posting.
ORGANIZATION CONTEXT & CULTURE
Merck is a global science and technology company operating across Healthcare, Life Science and Electronics.
TEAM SIZE: 60,000+ employees globally
INDUSTRY: Science and Technology; Pharmaceuticals and Life Science
Culture: Inclusive, flexible and collaborative culture emphasizing scientific innovation, personal development and career advancement.
EXPECTED CAREER ROADMAP
Potential progression into senior regulatory operations, submission management leadership, regulatory publishing management or broader Regulatory Affairs roles.
APPLICATION ADVISORY
Emphasize 9-10 years pharmaceutical experience, 3-6 years in submission management or eCTD publishing, Veeva Vault RIM expertise, Health Authority submission experience and vendor oversight.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.