Cencora Regulatory Informatics Specialist
- Cencora Hiring Regulatory Informatics Specialist | eCTD Publishing Role in Noida
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities:
- Eligibility / Qualifications
- Educational Qualification:
- Relevant Courses:
- Experience:
- Required Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Who can apply for this role?
- Is eCTD publishing experience mandatory?
- What tools are preferred for this role?
- What are the shift requirements?
- What is the job location?
Cencora Hiring Regulatory Informatics Specialist | eCTD Publishing Role in Noida
Cencora is hiring for the role of Specialist – Regulatory Informatics and Operations in the Consulting division at its Noida location. This opportunity is ideal for candidates with at least 3 years of experience in regulatory affairs, eCTD publishing, and dossier management within the pharmaceutical and life sciences industry.
This role focuses on regulatory submissions, dossier publishing, and informatics support across global health authorities, making it a strong career opportunity for professionals in regulatory operations and pharmaceutical compliance.
Company Overview
Cencora is a global healthcare solutions company committed to improving patient outcomes and advancing pharmaceutical innovation. Formerly known as AmerisourceBergen, the company operates at the center of healthcare by supporting pharmaceutical manufacturers, healthcare providers, and regulatory systems worldwide.
Through its affiliate PharmaLex, Cencora provides specialized services in regulatory affairs, pharmacovigilance, and clinical development. The company is recognized for its strong regulatory expertise, global presence, and commitment to compliance and quality in healthcare operations.
Job Role & Responsibilities
As a Regulatory Informatics Specialist, you will be responsible for managing regulatory submissions, dossier compilation, and publishing activities while ensuring compliance with global regulatory standards.
Key Responsibilities:
Regulatory Publishing & Submissions
- Support eCTD submissions across US and EU regions for multiple submission types
- Perform dossier compilation, publishing, and post-publishing activities
- Handle regulatory documents across Modules 1 to 5
- Ensure compliance with global regulatory submission standards and timelines
Regulatory Informatics & Operations
- Provide support for regulatory informatics systems and health authority requirements
- Participate in pre-publishing and submission validation processes
- Maintain accuracy and consistency in regulatory data and documentation
Client & Stakeholder Management
- Build and maintain client relationships
- Identify opportunities for additional regulatory support services
- Collaborate with cross-functional teams and regulatory leads
Eligibility / Qualifications
Educational Qualification:
Bachelor’s degree in Pharmacy or Science; M.Pharm preferred
Relevant Courses:
B.Pharmacy, M.Pharmacy, Pharm.D, BSc Life Sciences, MSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Regulatory Affairs
Experience:
- Minimum 3 years of experience in regulatory affairs or eCTD publishing
- Hands-on experience in US submissions is mandatory
Required Skills
- Strong knowledge of eCTD submission and publishing processes
- Experience with regulatory dossier modules (1–5)
- Familiarity with Veeva Vault and publishing tools (preferred)
- Understanding of US and EU regulatory requirements
- Good communication and stakeholder management skills
- Ability to work in US/CET shift timings
Location & Salary
- Job Location: Noida, India
- Work Type: Full-time
- Salary: Competitive salary package based on experience in regulatory affairs and publishing
Application Process
Interested candidates can apply through the official Cencora careers portal:
Frequently Asked Questions (FAQs)
Who can apply for this role?
Candidates with Pharmacy or Life Sciences degrees and at least 3 years of experience in regulatory affairs can apply.
Is eCTD publishing experience mandatory?
Yes, experience in eCTD submission and publishing is required.
What tools are preferred for this role?
Experience with Veeva Vault and publishing tools is preferred.
What are the shift requirements?
Candidates should be flexible to work in US or CET shifts.
What is the job location?
The role is based in Noida, India.
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To apply for this job please visit careers.cencora.com.
