Manager Regulatory Informatics and Operations

## Manager Regulatory Informatics and OperationsApply: APAC > India > Noida: Full time: Posted Today: R2616657Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# **Job Details*** Creation, compilation and validation of electronic submissions (e.g. 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 new 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* flexible to work US time shift.**Qualification:*** Bachelor's 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.