Manager – Regulatory Informatics and Operations

Job 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: Website
📞Contact: Contact us

🌟Regulatory submissions are where science meets precision. 🧬📋

A 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.

Adding leadership experience to expertise in platforms such as Veeva Vault can further expand opportunities into regulatory technology management and global operations. 📈🧬