JOB DESCRIPTION

R&D; – Regulatory Documentation & Technical Support

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 and 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, residual solvent, elemental impurity and mutagenic/genotoxic impurity assessments.
- Maintain supporting documents, references, certificates, analytical reports and responses required for DMF filing or amendments.
- Perform cross-checking of 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/updates.
- Support compilation of manufacturing process, process controls, specifications, analytical methods, impurity profile and 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

- ROS / Route of Synthesis
Prepare,



review and maintain detailed Route of Synthesis (ROS) documents, reaction schemes, process descriptions, quantities, conditions, work-up and isolation details.

- Risk Assessmen
Prepare/review risk assessments covering process risks, impurities, residual solvents, elemental impurities, mutagenic/genotoxic impurities and other relevant quality risks.

- Impurity Profile
Develop and maintain impurity profiles, including process-related impurities, degradation impurities, specified/unspecified impurities and potential carry-over impurities.

- Characterization Report
Prepare/review characterization reports using appropriate analytical data such as HPLC, GC, LC-MS/MS, NMR, FT-IR, DSC, TGA, XRD, UV and elemental analysis, as applicable.

- Structure Elucidation
Coordinate interpretation and documentation of analytical data for unknown/potential impurities and intermediates, including spectral assignments and proposed structures.

- 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/API chemistry and pharmaceutical process development.
- Working knowledge of DMF and CEP documentation requirements.
- Good understanding of ROS, impurity profiles, risk assessments and 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.

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.

13. Document Control

- Department - R&D; / Regulatory Documentation

- Position R& D – Regulatory Documentation & Technical Support

- Document Type - Job Description

- Version - 01

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

Perks:

- Provident Fund

Work Location: In person

📌 Research and Development Chemist (India)
🏢 Deccan Nutraceuticals
📍 India