PHARMAFull-time
Submission Manager - CMC
HYDERABAD (IN)ONSITEPOSTED: 8/12/2026
PHARMAFull-time
HIRING ORGANIZATIONBRISTOL MYERS SQUIBBPharmaceuticals
BR
ROLE DEFINITION & RESPONSIBILITIES
Manage and coordinate the planning, review, and timely delivery of Chemistry, Manufacturing, and Controls (CMC) regulatory submission dossiers.
Prepare submission content plans, cover letters, and official FDA forms for routine investigational and post-approval maintenance filings.
Support execution of global submission plans in close collaboration with internal cross-functional teams and external publishing vendors.
Conduct eCTD verification and quality checks on published dossiers to ensure strict compliance with Health Authority standards.
Manage translation documentation, non-eCTD submission coordination, regulatory tracking database entries, and legal due diligence support.
REQUIRED VERIFIED SKILLS
CMC Regulatory Submissions
eCTD Publishing
FDA Forms
Health Authority Guidelines
Regulatory Information Management (RIM)
Document Verification
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Bristol Myers Squibb is actively hiring for this position.
INDUSTRY: Pharmaceuticals
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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