Research And Development Officer

Job description:

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 regulatory compliance.

2. Key Responsibilities

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

3. DMF Filing Support

• Prepare and compile technical information for Drug Master File (DMF) submissions.
• Support documentation related to manufacturing process, process controls, specifications, analytical procedures, validation/verification, and stability.
• Compile and review process flow diagrams, batch information, raw material/KSM information, and critical process parameters.
• Coordinate impurity, residual solvent, elemental impurity, and mutagenic/genotoxic impurity assessments.
• Maintain supporting documents, certificates, analytical reports, references, and DMF amendment records.
• Cross-check data between development reports, specifications, analytical reports, and regulatory submissions.

4. CEP Documentation Support

• Coordinate preparation and compilation of technical documents for CEP applications, renewals, and updates.
• Support compilation of manufacturing process, specifications, analytical methods, impurity profile, and stability information.
• Review CEP technical packages for consistency with approved manufacturing and analytical information.
• Track commitments, variations/updates, and supporting documentation.

5. Technical & Scientific Documentation

• Prepare, review, and maintain Route of Synthesis (ROS), reaction schemes, process descriptions, quantities, conditions, work-up, and isolation details.
• Prepare/review risk assessments covering process risks, impurities, residual solvents, elemental impurities, and mutagenic/genotoxic impurities.
• Develop and maintain impurity profiles, including process-related, degradation, specified/unspecified, and carry-over impurities.
• Prepare/review characterization reports using HPLC, GC, LC-MS/MS, NMR, FT-IR, DSC, TGA, XRD, UV, and elemental analysis, as applicable.
• Coordinate structure elucidation of unknown/potential impurities and intermediates.
• Compile process development reports covering optimization, parameter justification, yield/purity improvement, and scale-up studies.

6. Impurity & Risk Assessment

• Evaluate potential impurities from starting materials, reagents, catalysts, solvents, intermediates, and process conditions.
• Prepare/review impurity fate, purge, and carry-over assessments.
• Support ICH M7, Q3C, and Q3D related assessments.
• Establish scientific justifications for proposed limits and specifications using analytical data, process capability, and applicable guidelines.

7. Analytical & Characterization Data Review

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

8. Regulatory Compliance & Documentation Control

• Maintain awareness of applicable ICH, pharmacopoeial, and regulatory requirements for APIs.
• Ensure documents are scientifically justified, consistent, traceable, and supported by source data.
• Maintain regulatory document master lists, pending actions, commitments, and document status.
• Support 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 specifications, batch records, analytical reports, certificates, and technical documents.
• Participate in technical meetings related to 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 ROS, impurity profiles, risk assessments, and characterization reports.
• Understanding of ICH guidelines, pharmacopoeial requirements, and API regulatory expectations.
• Ability to interpret analytical data and prepare scientifically sound justifications.
• Strong technical writing, documentation, 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, risk assessments, and impurity fate/purge assessments.
• Comprehensive characterization and structure-elucidation reports.
• Timely responses to regulatory/customer technical queries.
• Controlled and traceable regulatory document packages.

12. Performance Expectations

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
Experience : 3 - 4 yrs