R&D – Regulatory Documentation & Technical Support

Position: R&D – Regulatory Documentation & Technical Support

Department: R&D / Regulatory Documentation
Position: R&D – Regulatory Documentation & Technical Support
Document Type: Job Description

1. Job Purpose

To manage and support the preparation, review, compilation, and maintenance of technical and regulatory documentation for pharmaceutical/API development and manufacturing activities, ensuring scientific accuracy, data integrity, traceability, and compliance with applicable regulatory and quality requirements.

2. Key Responsibilities

• Prepare, review, and coordinate regulatory/technical documents required for DMF, CEP, and customer/regulatory submissions.
• Coordinate with R&D, Analytical, Production, QA, QC, RA, and external laboratories/consultants for collection and reconciliation of technical data.
• Review process, analytical, and development information for consistency across regulatory documents.
• Maintain document version control, change history, references, and supporting evidence.
• Support responses to regulatory/customer queries and provide technical clarifications in coordination with relevant functions.
• Ensure confidential handling of proprietary process and analytical information.

3. Regulatory Documentation – DMF Filing Support

• Prepare and compile technical information for Drug Master File (DMF) submissions.
• Support preparation/review of sections covering:
• Manufacturing process
• Process controls
• Specifications
• Analytical procedures
• Validation/verification
• Stability, as applicable
• Compile and review manufacturing process flow diagrams, batch manufacturing information, raw-material/KSM information, and critical process parameters.
• Coordinate preparation of:
• Impurity assessments
• Residual solvent assessments
• Elemental impurity assessments
• Mutagenic/genotoxic impurity assessments
• Maintain supporting documents, references, certificates, analytical reports, and responses required for DMF filing or amendments.
• Cross-check data between development reports, specifications, analytical reports, and regulatory submission documents.

4. CEP Documentation Support

• Coordinate preparation and compilation of technical documents required for Certificate of Suitability (CEP) applications, renewals, and updates.
• Support compilation of:
• Manufacturing process
• Process controls
• Specifications
• Analytical methods
• Impurity profile
• Stability information
• Review CEP-related technical packages for consistency with approved manufacturing and analytical information.
• Track commitments, variations/updates, and supporting documentation associated with CEP maintenance.

5. Technical & Scientific Documentation

A. Route of Synthesis (ROS)

• Prepare, review, and maintain detailed ROS documents.
• Document reaction schemes, process descriptions, quantities, conditions, work-up, and isolation details.

B. Risk Assessment

• Prepare/review risk assessments covering:
• Process risks
• Impurities
• Residual solvents
• Elemental impurities
• Mutagenic/genotoxic impurities
• Other relevant quality risks

C. Impurity Profile

• Develop and maintain impurity profiles covering:
• Process-related impurities
• Degradation impurities
• Specified/unspecified impurities
• Potential carry-over impurities

D. Characterization Reports

• Prepare/review characterization reports using appropriate analytical data, such as:
• HPLC
• GC
• LC-MS/MS
• NMR
• FT-IR
• DSC
• TGA
• XRD
• UV
• Elemental analysis

E. Structure Elucidation

• Coordinate interpretation and documentation of analytical data for unknown/potential impurities and intermediates.
• Support spectral assignments and proposed structure documentation.

F. Process Development Reports

• Compile development history, process optimization studies, parameter justification, yield/purity improvement studies, and scale-up information.

6. Impurity & Risk Assessment Responsibilities

• Evaluate potential impurities generated from starting materials, reagents, catalysts, solvents, intermediates, and process conditions.
• Prepare/review impurity fate and purge assessments and carry-over evaluations.
• Support mutagenic/genotoxic impurity assessments in line with applicable ICH M7 principles.
• Support residual solvent assessments in accordance with applicable ICH Q3C requirements.
• Support elemental impurity assessments in accordance with applicable ICH Q3D requirements.
• Establish scientific justifications for proposed limits/specifications using process capability, analytical data, and applicable guidelines.

7. Analytical & Characterization Data Review

• Review chromatographic and spectroscopic data for technical reports and regulatory documentation.
• Coordinate analytical testing and interpretation for unknown impurities and intermediates.
• Review analytical method suitability, system suitability, impurity reporting, detection/quantitation limits, and specification-related information.
• Ensure characterization data are appropriately linked to the proposed chemical structure and manufacturing stage.

8. Regulatory Compliance & Documentation Control

• Maintain awareness of applicable ICH, pharmacopoeial, and regulatory requirements relevant to API development and regulatory filings.
• Ensure documents are scientifically justified, internally consistent, traceable, and supported by source data.
• Maintain master lists of regulatory documents, pending actions, commitments, and document status.
• Support preparation of responses to deficiencies, technical questions, and customer questionnaires.

9. Cross-Functional Coordination

• Work closely with R&D, QA, QC, Production, Engineering, RA, Supply Chain, and external testing agencies.
• Coordinate collection of approved specifications, batch records, analytical reports, certificates, and supporting technical documents.
• Participate in technical meetings for review of regulatory observations, process changes, and documentation gaps.

10. Required Knowledge & Skills

• Strong knowledge of Organic Chemistry/API Chemistry and pharmaceutical process development.
• Working knowledge of DMF and CEP documentation requirements.
• Good understanding of:
• Route of Synthesis (ROS)
• Impurity profiles
• Risk assessments
• Characterization reports
• Understanding of ICH guidelines, pharmacopoeial requirements, and regulatory expectations applicable to APIs.
• Ability to interpret analytical data and prepare technically sound scientific justifications.
• Strong technical writing, document review, coordination, and communication skills.
• Strong attention to detail and ability to maintain accurate and traceable documentation.

11. Key Deliverables

• Accurate and submission-ready DMF/CEP technical documentation.
• Updated ROS and process-development documentation.
• Complete impurity profiles and impurity fate/purge assessments.
• Scientifically justified risk assessments.
• Comprehensive characterization and structure-elucidation reports.
• Timely responses to regulatory/customer technical queries.
• Controlled and traceable regulatory document packages.

12. Performance Expectations

The position is expected to deliver technically accurate, complete, traceable, and timely documentation while maintaining confidentiality and ensuring alignment between R&D source data, quality documents, and regulatory submission requirements.

Pay: ₹300,000.00 - ₹350,000.00 per year

Benefits:

• Provident Fund

Application Question(s):

• Do you have hands-on experience interpreting analytical/spectroscopic data such as LC-MS, NMR, CMR, and HPLC?
• Do you have hands-on experience preparing or compiling DMF and CEP documentation using R&D/process development data?
• Do you have strong knowledge of chemical/pharmaceutical processes and experience preparing or reviewing technical/process documentation?

Work Location: In person