Position: R&D; – Regulatory Documentation & Technical Support

Department: R&D; / Regulatory Documentation

Position: R&D; – Regulatory Documentation & Technical Support

Document Type:

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.
- Solid 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

📌 R&D – Regulatory Documentation & Technical Support (Alandi)
🏢 Deccan Nutraceuticals
📍 Alandi