JOB DESCRIPTION R&D – Regulatory Documentation & Technical Support1.
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
Pay: ₹300,000.00 - ₹350,000.00 per year
Benefits:
- Commuter assistance
- Food provided
- Provident Fund
Work Location: In person
