Manager - Regulatory Affairs

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Inviting applications for the role of Manager,Business Analyst – Regulatory/RIMS
We are seeking a Business Analyst (BA) with expertise in Veeva Vault RIM (Regulatory Information Management) implementation for pharmaceutical clients. The BA will be responsible for gathering business requirements, analyzing regulatory processes, defining system configurations, and ensuring seamless adoption of Veeva Vault. The role requires close collaboration with business stakeholders, IT teams, and Veeva consultants to optimize regulatory operations and compliance..

Responsibilities
•    Business Analysis & Requirement Gathering:
o    Work with business users and regulatory stakeholders to understand requirements and pain points.
o    Conduct discovery sessions, workshops, and gap analysis to define system needs.
o    Document business processes, functional requirements, user stories, and use cases.
o    Support data migration strategies by analyzing regulatory data and defining data mapping rules.
•    System Implementation & Configuration Support:
o    Define metadata, document types, templates, and workflows in Veeva Vault.
o    Work with IT teams and vendors to align Veeva Vault configurations with regulatory needs.
o    Support integration between Veeva Vault and other enterprise systems (e.g., SAP, Salesforce, EDMS).
•    Regulatory & Compliance Alignment:
o    Ensure the system aligns with global regulatory standards (GxP, 21 CFR Part 11, IDMP, xEVMPD, etc.).
o    Provide business insights on regulatory submissions, dossier management, and health authority interactions.
o    Identify areas for process improvement and compliance enhancement.
•    Life Sciences Regulatory Domain Knowledge & Compliance Alignment:
o    Strong knowledge of pharmaceutical regulatory information management system (RIMS), including: 
    Product management
    Registration process
    Submissions
    Health Authority interactions (FDA, EMA, MHRA, etc.)
    Dossier management and archiving
    Document Management
•    Experience with global regulatory compliance standards such as: 
o    GxP, 21 CFR Part 11, IDMP, xEVMPD
o    Regulatory submission tracking and change control processes
o    Provide recommendations for business process improvements and regulatory compliance enhancements
General tasks:
•    Conduct requirement discussion workshop and collect requirements
•    Author user stories and acceptance criteria or functional or configuration specification
•    Coordinate with configuration team on implementation of user requirements
•    Coordinate with business team to define business processes
Experience:
•    Relevant years of experience as a Business Analyst in Life Sciences Regulatory domain (Pharma/Biotech).
•    Hands-on experience with Veeva Vault RIM modules (Registrations, Submissions, Submissions Archive, etc.).
•    Knowledge of regulatory submission processes, dossier management, and compliance requirements.
•    Experience in system integration and data migration projects within regulatory frameworks.
•    Understanding of business process optimization and automation in regulatory operations..
Qualifications we seek in you!
Minimum Qualifications

•    Atleast Bachelor's degree required  in for Pharmaceutical: science, engine