Senior Associate – Regulatory Information Management

Posted 10 Hours Ago
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Mumbai, Maharashtra, IND
In-Office
Senior level
Biotech
The Role
Execute new product creation and updates in PIM while maintaining accurate, complete, traceable product records and regulatory documentation. Perform quality checks, correct non-conformities, follow approved workflows, and support audit-ready delivery. Respond to stakeholder queries, track pending actions, coordinate escalations, and maintain governance records. Identify recurring issues and process gaps, and contribute to continuous improvement through updated templates, checklists, and system enhancements.
Summary Generated by Built In

Main Responsibilities

     The main responsibilities of the role include, but are not limited to, the following:

RIM Execution (New Product Creation & Product Updates/Enrichment)

  • Execute new product creation and product updates/enrichment in PIM, ensuring product records are accurate, complete, and processed in line with defined workflows and service expectations.
  • Perform detailed checks to ensure correct linkage between product records, regulatory/technical documents, required fields, and supporting evidence.
  • Apply approved process updates and regulatory trade control/documentation changes into product records as directed through defined workflows and guidance.

Documentation, Data Integrity & System Discipline

  • Maintain high-quality product data and related records in PIM and connected systems, ensuring traceability, version control, and disciplined recordkeeping.
  • Ensure product records are enriched with current regulatory and technical documentation, including compliance statements, specifications, technical data sheets, declarations, certificates, or attestations as applicable.
  • Identify missing, outdated, inconsistent, or incomplete documentation and coordinate follow-ups through defined escalation and closure routes.

Quality Checks, Non-Conformities & Process Adherence

  • Execute self-checks, peer checks, and defined quality review steps to ensure first-time-right outcomes and reduce rework.
  • Support closure of non-conformities, documentation gaps, and recurring errors by correcting records, capturing learnings, and following preventive actions.
  • Follow approved work instructions, checklists, naming conventions, approval steps, and evidence requirements to ensure audit-ready delivery.

Stakeholder Support & Operational Follow-Up

  • Support internal stakeholders by responding to RIM-related queries, clarifying missing inputs, and coordinating with the Process Lead / Team Lead / Specialist for complex cases.
  • Maintain disciplined follow-ups on pending information, open actions, and dependencies to support timely request closure.
  • Document key clarifications, decisions, and assumptions where required to ensure repeatability and consistency of future execution.

Service Governance & Continuous Improvement

  • Contribute to assigned workstream efforts by maintaining accurate trackers, records, and inputs for performance visibility and service governance.
  • Proactively flag bottlenecks, recurring issues, documentation challenges, or process gaps to the Process Lead / Team Lead.
  • Support continuous improvement by adopting updated templates, checklists, and system/process enhancements that improve quality, consistency, and execution efficiency.
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    The Company
    HQ: Antwerp
    2,676 Employees

    What We Do

    As a leading global innovation service provider in the specialty chemicals and food ingredients industry, we are committed to creating value for principals and customers whilst providing a great work environment and career opportunities. Azelis has 4,200+ employees across 65 countries worldwide. We work with around 2,800 principals to provide a diverse range of innovative products/services to 63,000+ customers. Our industry-dedicated sales teams have specialist product and application knowledge, combined with business know-how, enabling us to add value in all business relationships. We’re always looking to add new talent to our team and encourage and support the personal and professional growth of all employees. Specialties include: Life Sciences: Personal Care, Home Care & Industrial Cleaning, Pharma & Healthcare, Food & Nutrition, Animal Nutrition, Agricultural & Environmental Industrial Chemicals: CASE, Electronics, Essential Chemicals, Fine Chemicals, Advanced Materials & Additives, Chemicals, Lubricants & Metal Working Fluids, Other Applications, Textiles, Leather & Paper At Azelis, our partnerships with customers and principals remain at the heart of our activities. As a leading global innovation service provider, our entrepreneurial approach to doing business is reflected in our can-do attitude. Across our network of more than 70 application laboratories, our award-winning staff help develop formulations and provide technical guidance along the customers’ product development process. We combine a global market reach with a local footprint to offer a reliable, integrated and unique digital service to customers and attractive business opportunities to principals. Striving to create a positive impact on the environment and communities around the world, we are top-industry-rated by Sustainalytics. Azelis is a leader in sustainability. We aim to provide effective, sustainable, and reliable solutions. Our business is your business

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