Manager Regulatory Informatics and Operations

Cencora · Noida, India

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RegulatoryFull timeCompany career page

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Role summary

Cencora seeks a Manager of Regulatory Informatics and Operations to oversee electronic submission dossiers, regulatory systems management, and team training. The role requires expertise in eCTD preparation, regulatory compliance, and operational quality assurance across multiple jurisdictions.

What they're looking for

Bachelor's degree in life sciences, pharmacy, biomedical sciences, public health, or related field
8+ years in scientific consulting, healthcare, life sciences, or related field
2+ years management experience
Proficiency with Veeva Vault (RIMS and publishing modules preferred)
Strong understanding of US regulatory submission requirements for INDs, NDAs, datasets, and STFs
Experience with eCTD, SPLs, NeeS, and electronic submission gateways
Certification in clinical research, regulatory affairs, or related discipline (preferred)

What you'll be doing

Create, compile, and validate electronic regulatory submissions for MAAs, PSURs, amendments, variations, and renewals
Submit regulatory dossiers to competent authorities through electronic submission portals
Develop and maintain SOPs, work instructions, and quality assurance procedures for regulatory operations
Test and evaluate electronic tools for regulatory compliance and system changes
Train regulatory operations teams on software solutions and authority requirements

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