Manager Regulatory Informatics and Operations

World Courier; Dadri; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Cencora is hiring a Manager Regulatory Informatics and Operations for APAC (India/Noida). The role focuses on creating and validating electronic regulatory submissions (eCTD/NeeS) and ensuring quality in Regulatory Operations.

The position requires extensive experience in regulatory affairs within life sciences, plus management experience. Flexibility to work US time shifts is mentioned as a consideration.

Qualifications

• 8+ years of experience in scientific consulting, healthcare, life sciences, or a related field.
• 2+ years of experience in a management capacity.
• Certification in clinical research or regulatory affairs, health economics, outcomes research, or real-world evidence methodologies, or equivalent preferred.

Responsibilities

• Creation, compilation and validation of electronic submissions for regulatory activities (eCTD, NeeS).
• Electronic submission of dossiers to authorities via gateways and portals.
• Quality assurance in Regulatory Operations; SOPs, WI training.

Skills

Regulatory operations

Team management

GxP knowledge

Education

Bachelor's degree in life sciences

Job description

## 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.