Senior Regulatory Operations Specialist I
Location: Pune, India
Work Mode: Hybrid
Employment Type: Full-Time
Job Requisition ID: 262893
Application Deadline: June 6, 2026
Position Summary
The Senior Regulatory Operations Specialist I is responsible for supporting global regulatory affairs operations through the preparation, compilation, review, and maintenance of Chemistry, Manufacturing & Controls (CMC) documentation and other regulatory submissions. The role supports pharmaceutical product registrations, post-approval lifecycle management, labeling activities, supplier coordination, stability assessments, change control evaluations, and regulatory compliance initiatives.
This position also requires Japanese language expertise to support communication with Japanese regulatory authorities, suppliers, and cross-functional stakeholders, including translation and business correspondence activities.
Key Responsibilities
Regulatory Documentation & Submission Support
Prepare, compile, review, and maintain CMC and regulatory documentation for:
New product registrations
Regulatory submissions
Product lifecycle maintenance
Post-approval variations and amendments
Ensure submission packages comply with global regulatory requirements and internal quality standards.
Support regulatory filing activities across international markets.
CMC Documentation Management
Prepare and maintain:
Raw Material Specifications
Packaging Material Specifications
Product Specifications
Supporting Technical Documents
Review regulatory documentation for accuracy, completeness, and compliance.
Support specification development and scientific justification activities.
Change Control & Regulatory Impact Assessment
Coordinate with cross-functional teams to assess regulatory impact of:
Manufacturing changes
Process modifications
Supplier changes
Product quality events
Participate in change control evaluations and implementation planning.
Support documentation associated with:
OOS (Out of Specification) investigations
OOT (Out of Trend) investigations
Product quality deviations
Corrective and Preventive Actions (CAPA)
Labeling Operations Support
Support creation, review, and maintenance of:
Global Labeling Documents
Labeling Change Packages
Quality Control Reviews
Product Information Updates
Ensure labeling documentation remains compliant with regulatory requirements.
Stability & Technical Evaluation
Support stability program activities including:
Stability Data Review
Stability Trend Analysis
Stability Report Preparation
Perform:
Dissolution Profile Evaluation
Product Performance Assessments
Scientific Data Interpretation
Regulatory Research & Scientific Support
Conduct scientific literature searches and regulatory intelligence activities.
Prepare regulatory support documents for:
Active Pharmaceutical Ingredients (APIs)
Excipients
Drug Products
Analyze regulatory requirements and support submission strategies.
Supplier & Business Operations Support
Support:
Supplier Data Management
Purchase Order (PO) Creation
Business Plan File Maintenance
Financial Data Management Activities
Coordinate with vendors and internal departments to maintain regulatory compliance.
Import License & Regulatory Coordination
Coordinate documentation related to:
Import Licenses
Regulatory Investigations
Compliance Reports
Regulatory Correspondence
Maintain records and ensure proper document management practices.
Collaborate with internal and external stakeholders throughout regulatory processes.
Quality Systems & Compliance
Support laboratory quality and compliance initiatives.
Participate in:
Computerized System Validation (CSV)
System Qualification Activities
Software Upgrade Assessments
Validation Documentation
Ensure compliance with:
GMP Requirements
Regulatory Guidelines
Internal SOPs
Quality Standards
Japanese Regulatory & Communication Support
Language Requirement
Minimum JLPT N3 Certification (mandatory).
Strong proficiency in:
Japanese Business Communication
Business Email Writing
Professional Correspondence
Responsibilities
Support communication with Japanese regulatory agencies and suppliers.
Translate regulatory and technical documents:
Japanese → English
English → Japanese
Coordinate with Japan-based stakeholders and Regulatory Affairs teams.
Facilitate effective communication across global teams.
Educational Qualifications
Required
Bachelor’s or Master’s Degree in:
Pharmacy (B.Pharm / M.Pharm)
Pharmaceutical Sciences
Life Sciences
Chemistry
Biotechnology
Related Scientific Discipline
Experience Requirements
Preferred Experience
Experience in one or more of the following:
Regulatory Affairs
Regulatory Operations
CMC Documentation
Pharmaceutical Quality Systems
Global Regulatory Submissions
Product Lifecycle Management
Labeling Operations
Change Control Management
Pharmaceutical Manufacturing Support
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Tuscaloosa |D.C :
Washington |Delaware :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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China | Quarry Bay |Liaoning :
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Queensland |Melbourne :
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Canada |Quebec :
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Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
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