Manager Regulatory Informatics and Operations

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 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

  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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