Standard Operating Procedure for RACI Definition and Responsibility Assignment in Regulatory Projects

Department	Regulatory Affairs
SOP No.	RA/2026/788
Supersedes	NA
Page No.	1 of X
Issue Date	17/04/2026
Effective Date	17/04/2026
Review Date	17/04/2028

Purpose

This Standard Operating Procedure (SOP) establishes a consistent and practical approach for defining RACI (Responsible, Accountable, Consulted, and Informed) roles and responsibilities within regulatory projects. Its objective is to facilitate clear accountability, streamline cross-functional coordination, enhance communication effectiveness, and ensure compliance with internal quality and regulatory requirements in regulatory affairs activities.

Scope

This SOP applies to all regulatory projects undertaken within the organization involving any regulatory functional area, including but not limited to submission management, dossier preparation, regulatory intelligence, and correspondence handling. It covers all phases of regulatory projects across departments interfacing with regulatory affairs such as Quality Assurance, Quality Control, Manufacturing, Engineering, and Documentation. This procedure excludes non-regulatory projects and activities handled solely by other departments without regulatory involvement.

Responsibilities

The following functional roles are involved in the execution and oversight of regulatory project activities:

• Regulatory Project Manager: Responsible for coordinating RACI definition, project planning, and tracking role assignments.
• Regulatory Affairs Lead: Oversees regulatory content development, submission accuracy, and compliance adherence.
• Quality Assurance Representative: Reviews compliance and quality impact related to regulatory deliverables.
• Cross-Functional Team Members: Perform assigned responsibilities, provide inputs, and participate in consultations as defined in the RACI.
• Document Control Specialist: Ensures proper documentation and archiving of RACI matrices and project records.

Accountability

The Regulatory Affairs Head is accountable for the implementation, compliance, periodic review, escalation, and ensuring the ongoing effectiveness of this SOP. This role ensures training, dissemination, and integration of RACI practices into regulatory project management and governance frameworks.

Procedure

The procedure for defining RACI roles and responsibilities in regulatory projects consists of the following detailed steps to ensure clarity, effective communication, and compliance:

1. Preparation and Project Initiation: Upon project initiation, the Regulatory Project Manager reviews project objectives, key deliverables, and involved functions. All relevant stakeholders across departments are identified and engaged early.

2. Drafting the RACI Matrix: Using a standardized RACI template, the Regulatory Project Manager lists tasks, activities, or decision points critical to the project. For each task, roles are assigned as follows:

• Responsible (R): Individuals or roles who perform the work.
• Accountable (A): Single role owning the end-to-end completion and decision-making authority.
• Consulted (C): Subject matter experts or stakeholders providing input.
• Informed (I): Those kept up-to-date on progress or outcomes.

The matrix may include regulatory writing, document review, submission preparation, quality checks, and final approvals.

3. Review and Validation: The draft RACI matrix is circulated among all identified stakeholders, including cross-functional team members, for feedback. This step ensures appropriate role assignment and prevents overlapping or gaps in responsibility.

4. Finalization and Approval: After incorporating feedback, the Regulatory Affairs Lead reviews and endorses the finalized RACI assignment. The Regulatory Affairs Head provides final approval to formalize the RACI document.

5. Communication and Training: The approved RACI matrix is disseminated to all involved personnel. Training or briefing sessions may be conducted to clarify role expectations and workflow interactions, ensuring all stakeholders understand their responsibilities.

6. Execution and Monitoring: Throughout the project, assigned roles perform their designated tasks in alignment with the RACI matrix. The Regulatory Project Manager monitors adherence, identifies role conflicts, and facilitates resolution where needed.

7. Documentation and Record Keeping: All RACI matrices, communications, and approvals are documented and stored according to internal document control procedures. Records are retained for audit readiness and traceability.

8. Periodic Review and Updates: For ongoing or multi-phase projects, the RACI matrix is periodically reviewed for relevance and updated to reflect changes in team composition, scope, or regulatory requirements.

9. Handling Deviations: Any deviations from assigned roles or responsibilities are formally documented, investigated, and resolved as part of continuous improvement and compliance efforts.

This comprehensive approach ensures clear assignment of regulatory project roles, reduces ambiguity, promotes accountability, and supports efficient regulatory submissions and compliance.

Abbreviations

RACI: Responsible, Accountable, Consulted, Informed
SOP: Standard Operating Procedure
QA: Quality Assurance
RA: Regulatory Affairs
QC: Quality Control

Documents

1. RACI Matrix Template for Regulatory Projects (Annexure-1)
2. RACI Review and Approval Log (Annexure-2)
3. Training Record on RACI Roles and Responsibilities (Annexure-3)

References

International Council for Harmonisation (ICH) Q10 Pharmaceutical Quality System,
ICH Q9 Quality Risk Management,
Good Manufacturing Practices (GMP) Guidelines,
ISO 9001:2015 Quality Management Systems,
Company Quality Manual and Regulatory Project Management Policies.

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: RACI Matrix Template for Regulatory Projects

Purpose: To systematically capture and communicate roles and responsibilities by task/activity for regulatory projects ensuring clarity and accountability.

Task/Activity	Responsible (R)	Accountable (A)	Consulted (C)	Informed (I)
Regulatory Dossier Preparation	Regulatory Affairs Specialist	Regulatory Affairs Lead	Quality Assurance, Clinical Team	Project Manager, Documentation
Submission Review and Approval	Regulatory Affairs Specialist	Regulatory Affairs Head	Quality Assurance, Legal	Manufacturing, Supply Chain
Regulatory Intelligence Gathering	Regulatory Affairs Analyst	Regulatory Affairs Lead	Clinical Affairs, QA	Project Manager
Communication with Regulatory Authorities	Regulatory Affairs Specialist	Regulatory Affairs Head	Legal, QA	Cross-Functional Team

Annexure-2: RACI Review and Approval Log

Purpose: To document the review and approval steps for the finalized RACI matrix ensuring formal authorization and traceability.

Review Date	Reviewer Role	Comments	Status (Approved/Rejected)	Signature/Initials
05/04/2026	Regulatory Affairs Lead	Reviewed role assignments; no changes needed	Approved
10/04/2026	Quality Assurance Representative	Confirmed compliance alignment with QA requirements	Approved
15/04/2026	Regulatory Affairs Head	Final approval for implementation	Approved

Annexure-3: Training Record on RACI Roles and Responsibilities

Purpose: To record attendance and details of training sessions conducted to familiarize staff with the RACI framework and their assigned roles in regulatory projects.

Training Date	Department	Trainer	Topic Covered	Attendees	Signature of Attendees
20/04/2026	Regulatory Affairs	Compliance Officer	RACI Definition and Role Clarity in Regulatory Projects	Regulatory Specialists, Project Managers
21/04/2026	Quality Assurance	Quality Manager	Integrating RACI in Quality and Compliance Processes	QA Analysts, Documentation Staff

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
17/04/2026	1.0	Initial issue	New SOP creation