Senior Analyst - Regulatory Submission Management
Job Id: 285210
Location: Electronic City, Bangalore, Karnataka, India
Job Type: Full-time
About the Role
As a Senior Analyst – Regulatory Submission Management, you will be responsible for handling regulatory submissions, quality checks, and document management processes in compliance with global health authority requirements. Your role will involve working with eCTD format submissions, Veeva Vault RIM (Breeze), and eRDMS, ensuring accuracy, timely completion, and proper archival of regulatory records. The ideal candidate will have expertise in regulatory operations, document management, and technical support for regulatory systems.
Key Responsibilities
Create submissions in eCTD format and perform quality checks of the dossier for submission to various health authorities (Publishing).
Develop and maintain the Submission Content Plan (SCP) for submissions to various customers.
Upload, archive, and maintain CMC documents and submission records in Veeva Vault RIM.
Manage record creation and maintenance for site registrations in eRDMS (Breeze).
Oversee end-to-end record creation for various regulatory activities in Veeva Vault RIM.
Create and submit KPI reports quarterly for on-time registrations.
Provide Veeva Vault training for new users at the global level and offer technical support to Subject Matter Experts.
Create Health Authority queries for Pharma and Food Materials in RIM and track them to closure.
Perform data correctness checks in eRDMS through reporting and user support.
Qualifications
Education: Master’s degree or PhD in Pharma, Regulatory Affairs, or a related field.
Experience: 3-6 years of experience in regulatory affairs, including registrations, publishing, renewals, QC, validations, and regulatory submission processes in eCTD format.
Skills:
Excellent communication and collaboration skills to work with cross-functional teams.
Ability to provide training and technical support.
Strong analytical and problem-solving skills for data verification and reporting.
What We Offer
We celebrate diversity and believe it drives excellence and innovation. Our inclusive culture encourages personal growth and collaboration, empowering everyone to make a meaningful impact.
Apply now and become a part of our diverse team!
Gujarat :
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Siliguri |Illinois :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Croatia |Zagreb :
Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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