Cencora is hiring a Specialist โ Regulatory Informatics and Operations in Noida, India. This full-time opportunity is suitable for B.Pharm, M.Pharm, and Science graduates with at least 3 years of relevant experience in regulatory operations, submission publishing, eCTD submissions, or regulatory informatics.
The Cencora Regulatory Informatics Specialist job involves supporting regulatory processes, including dossier compilation, pre-publishing, dossier publishing, post-publishing activities, and Health Authority submissions.
Candidates with experience in US Publishing, EU eCTD submissions, Veeva Publishing, and regulatory dossier management may find this opportunity particularly relevant.
Cencora Job Overview
| Job Details | Information |
|---|---|
| Company | Cencora |
| Affiliated Company | PharmaLex India Private Limited |
| Job Role | Specialist โ Regulatory Informatics and Operations |
| Job Location | Noida, India |
| Employment Type | Full-time |
| Qualification | B.Pharm / Science Degree / M.Pharm Preferred |
| Experience | Minimum 3 Years |
| Job Requisition ID | R265000 |
| Key Skill | Submission Publishing |
| Preferred Tool | Veeva Publishing |
| Shift Requirement | CET/US shifts may be required |
About the Cencora Regulatory Informatics Job
The Specialist โ Regulatory Informatics and Operations role supports regulatory submission activities across different Health Authority regions.
The selected candidate will contribute to regulatory processes involving dossier Modules 1 to 5, applicable document types, and submission activities. The role includes participation in pre-publishing, dossier compilation, dossier publishing, and post-publishing operations.
A strong understanding of US and EU eCTD submissions is important for this Regulatory Informatics and Operations position. Candidates with US Publishing experience and familiarity with Veeva tools will have relevant expertise for the role.
Key Responsibilities
As a Regulatory Informatics and Operations Specialist, you will be responsible for:
- Developing and maintaining client relationships.
- Identifying opportunities for increased service support and communicating them to the respective lead.
- Supporting Regulatory Informatics and Operations processes.
- Providing support for regulatory dossier activities across Modules 1 to 5.
- Working with applicable regulatory document types and Health Authority regions.
- Supporting pre-publishing activities.
- Assisting with dossier compilation.
- Performing dossier publishing activities.
- Supporting post-publishing activities.
- Participating in informatics-related Health Authority initiatives.
- Supporting regulatory submission processes.
- Working with US and EU eCTD submissions across applicable submission types.
- Following established regulatory processes and operational requirements.
- Working in CET or US time zones when required.
Qualifications Required
Candidates applying for the Cencora Regulatory Informatics Specialist job in Noida should have:
- B.Pharm, or
- Another relevant Science degree.
Preferred Qualification
- M.Pharm
Experience Required
Applicants should have:
Minimum 3 years of relevant experience
Relevant experience in regulatory operations, regulatory publishing, eCTD submissions, or dossier management may be beneficial.
Required Skills and Knowledge
Mandatory Skill
- Submission Publishing
- US Publishing Experience
Preferred Skills
- Veeva Tool experience
- Veeva Publishing experience
Technical Knowledge
Candidates should have a good understanding of:
- Regulatory Informatics and Operations
- Regulatory processes
- Dossier management
- Dossier Modules 1 to 5
- Dossier compilation
- Pre-publishing
- Dossier publishing
- Post-publishing
- US eCTD submissions
- EU eCTD submissions
- Health Authority requirements
- Regulatory submission processes
Work Schedule and Flexibility
Candidates should be prepared to work according to business requirements.
The job description specifies that candidates should:
- Be able to work in CET/US shift time zones.
- Be open to working in shifts, if required.
Why Consider This Cencora Regulatory Affairs Job?
The Cencora Regulatory Informatics and Operations job offers an opportunity to work in an international regulatory environment supporting regulatory submission and publishing processes.
Professionals in this role may gain exposure to:
- Regulatory Informatics and Operations
- Global regulatory submission processes
- US and EU eCTD submissions
- Dossier publishing
- Health Authority requirements
- Regulatory dossier compilation
- Veeva Publishing tools
- Client support and stakeholder collaboration
This role can be relevant for professionals looking to build or strengthen a career in Regulatory Affairs, Regulatory Operations, eCTD Publishing, and Regulatory Informatics.
Who Should Apply?
This Cencora job in Noida may be suitable for:
- B.Pharm graduates with regulatory operations experience.
- M.Pharm professionals interested in regulatory careers.
- Science graduates with relevant regulatory experience.
- Regulatory Affairs professionals with at least three years of experience.
- Professionals experienced in submission publishing.
- Candidates with US Publishing experience.
- Regulatory publishing professionals familiar with eCTD submissions.
- Candidates with Veeva Publishing experience.
How to Apply
