Responsibilities
Creation, compilation and validation of electronic submissions (eCTD, NeeS) for all types of regulatory activities (e.g. MAAs, PSUR, amendments, variations, renewals) in ICH and non-ICH-areas using available software
Electronic submission of dossiers to competent authorities via electronic submission gateways and applicable portals
Quality assurance in the field of Regulatory Operations (e.g. preparation of SOPs and WIs and corresponding training)
Testing of electronic tools for recent requirements concerning regulatory operations: requirements for validation, changes in eCTD-structure, STED, VNeeS
Training of Regulatory Operations topics, software solutions and requirements stipulated by authorities within and outside of Regulatory Affairs
Experience with Veeva Vault (RIMS and publishing preferred); extensive US publishing understanding for complete submissions like INDs/NDAs, ability to handle datasets and STFs
SPLs
Validation errors troubleshooting




Adaptable to work US time shift

Qualifications
Bachelors degree in life sciences, pharmacy, biomedical sciences, public health, or a related field, or equivalent experience required.
Experience Skills: 8+ years of experience in scientific consulting, healthcare, life sciences, or a related field required. 2+ years of experience in a management capacity required. Certification in clinical research or regulatory affairs, health economics, outcomes research, or real-world evidence methodologies, or equivalent preferred.

Job Type

Full time

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📌 Manager Regulatory Informatics And Operations Noida
🏢 Amerisource Bergen
📍 Noida