Manager – Regulatory Informatics and Operations

Getsetjobs; Dadri; On-site; INR 2,000,000 - 3,000,000; Full time

Job summary

Cencora is seeking a Manager - Regulatory Informatics and Operations to lead electronic submissions, regulatory technology operations and quality processes across global markets. You will manage eCTD/NeeS publishing, support MAAs, PSURs, variations and renewals, and drive training on regulatory systems.

Located on-site in Noida, Uttar Pradesh, India, the role requires 8+ years in scientific/healthcare fields with at least 2 years in management, and strong experience with US INDs/NDAs and

Qualifications

• 8+ years in science/healthcare, with 2+ years in a management role.
• Experience with electronic regulatory submissions and publishing workflows.
• Strong knowledge of US regulatory publishing, eCTD, and NeeS requirements.

Responsibilities

• Create, compile and validate electronic submissions including eCTD and NeeS.
• Lead regulatory informatics and technology operations across global markets.
• Train teams on regulatory systems, processes and tools (eCTD, Veeva Vault).
• Audit, QA, and improve submission quality and timelines.

Skills

Regulatory informatics

Regulatory operations

eCTD/NeeS publishing

Veeva Vault (RIM & Publishing)

US regulatory submissions (INDs/NDAs)

Education

Bachelor's in Life Sciences/Pharmacy/Biomedical Sciences/Public Health

Tools

Veeva Vault

eCTD/NeeS tooling

Job description

# Manager - Regulatory Informatics and Operations### Description**Job ID**: R2616657| **Company**: Cencora| **Location**: Noida, Uttar Pradesh, India | **Job Type**: Full-time| **Work Mode**: On-site| **Experience**: 8+ years, including 2+ years in a management role| **Education**: Bachelor's in Life Sciences, Pharmacy, Biomedical Sciences, Public Health or related field| **Expected Salary**: ₹20-₹30 Lakhs Per Year| **Job Category**: Healthcare, Regulatory Affairs, Regulatory Operations, Life Sciences, Regulatory Informatics| **Website**:| **Contact**:-** | Regulatory submissions are where science meets precision. | **JobsA single submission can involve thousands of documents, multiple markets, strict technical standards and demanding timelines.Cencora is looking for a Manager - Regulatory Informatics and Operations to lead complex electronic submissions, regulatory technology operations and quality processes across global markets.-** | About Cencora:**Cencora is a global healthcare company focused on creating healthier futures and supporting pharmaceutical, healthcare and life-sciences organizations.Its teams work across healthcare services, pharmaceutical solutions and related capabilities, helping organizations navigate complex healthcare needs and deliver value to patients, providers and partners. |-** | About the Role:**As Manager - Regulatory Informatics and Operations, you will manage critical regulatory submission activities and technology-enabled processes supporting Regulatory Affairs.The role involves eCTD/NeeS publishing, regulatory submissions, Veeva Vault, submission validation, quality assurance, regulatory systems and stakeholder training.You will also support global submission activities across ICH and non-ICH regions while working with US regulatory requirements and electronic submission platforms.-** | Key Responsibilities:*** Create, compile and validate electronic submissions including eCTD and NeeS.* Support regulatory activities such as MAAs, PSURs, amendments, variations and renewals.* Submit regulatory dossiers through competent-authority gateways and applicable portals.* Perform quality assurance activities across Regulatory Operations.* Develop and maintain SOPs and Work Instructions.* Test electronic regulatory tools against new authority requirements.* Support changes involving eCTD structures, STED and VNeeS requirements.* Train teams on Regulatory Operations processes, software solutions and regulatory requirements.* Work extensively with Veeva Vault RIM and publishing.* Support complete US submissions including INDs and NDAs. * Handle datasets, STF-related activities and SPLs.* Troubleshoot electronic submission validation errors.* Manage regulatory operations stakeholders and ensure timely delivery.* Work flexible US-time shifts when required. |-** | Requirements:*** 8+ years of experience in scientific consulting, healthcare, life sciences or a related field.* At least 2 years of experience in a management capacity.* Strong knowledge of Regulatory Informatics and Regulatory Operations.* Hands-on experience with electronic regulatory submissions.* Strong understanding of eCTD and NeeS submissions.* Experience with Veeva Vault, preferably RIM and Publishing.* Extensive understanding of US regulatory publishing and submissions such as INDs and NDAs.* Experience handling datasets, STFs and SPLs.* Strong validation-error troubleshooting skills.* Excellent communication and stakeholder-management abilities.* Willingness to work US-time shifts.-** | Preferred Skills:*** Veeva Vault RIM* Veeva Vault Publishing* eCTD publishing* NeeS submissions* Regulatory submission management* US regulatory operations* IND and NDA submissions* PSURs and lifecycle management* SPLs and STFs* Submission validation* Regulatory systems implementation* SOP and Work Instruction development* Regulatory technology training* Quality assurance* Clinical and pharmaceutical regulatory processes-** | Career Insight:**Regulatory Operations is becoming increasingly technology-driven.Professionals who understand both regulatory requirements and digital submission platforms can build careers across regulatory publishing, regulatory informatics, submission management and life-sciences technology.Discover morejobRecruitment & StaffingrecruitAdding leadership experience to expertise in platforms such as Veeva Vault can further expand opportunities into regulatory technology management and global operations. |-LocationExperience5 Year## Job SkillsDiscover moreRecruitmentLabor & Employment LawJob ListingsCompensation & Benefits