CLAPS Industries Pvt. Ltd., a leading Pharmaceutical and Nutraceutical Manufacturing company, is inviting applications for the position of International Regulatory Affairs Executive / Sr. Executive (ROW Market). This opportunity is ideal for regulatory professionals with 2–5 years of experience who are looking to build a career in global pharmaceutical compliance and international market registrations.

The position is based at Infinity Tower, Prahlad Nagar, Ahmedabad, Gujarat, and requires candidates who can join immediately.

Job Overview

Position: International Regulatory Affairs Executive / Sr. Executive (ROW Market)
Experience: 2–5 Years
Industry: Pharmaceutical & Nutraceutical Manufacturing
Location: Ahmedabad, Gujarat
Joining: Immediate

Key Responsibilities

1. Dossier Development & Submission

• Prepare, compile, review, and submit regulatory dossiers (CTD/eCTD/ACTD) for ROW markets.
• Ensure compliance with country-specific regulatory requirements.
• Coordinate with R&D, QA, QC, Production, and Packaging teams for documentation.

2. Regulatory Compliance & Review

• Review product artworks, labels, and packaging materials.
• Conduct gap analysis and implement corrective actions.
• Ensure compliance with GMP, GLP, and applicable regulatory standards.

3. Regulatory Lifecycle Management

• Handle product variations, renewals, and post-approval changes.
• Maintain regulatory databases and registration records.

4. Documentation & Data Management

• Review technical documents, specifications, stability reports, and Certificates of Analysis (CoAs).
• Maintain document control as per internal SOPs and regulatory guidelines.

5. Regulatory Intelligence

• Monitor global regulatory updates and changing market requirements.
• Communicate new regulatory expectations to management and relevant departments.

6. Cross-Functional Support

• Support product development and commercialization activities.
• Assist QA teams during audits and inspections.

7. Continuous Improvement

• Participate in CAPA activities and internal quality improvement programs.
• Contribute to process optimization and compliance enhancement initiatives.

Why Join CLAPS Industries?

• Global regulatory exposure across multiple international markets.
• Professional growth opportunities in Regulatory Affairs.
• Strong quality and compliance culture.
• Collaborative work environment.
• Opportunity to contribute to global healthcare solutions.

Required Skills

• Knowledge of CTD, eCTD, and ACTD submissions.
• Understanding of GMP, GLP, and pharmaceutical regulations.
• Documentation and dossier preparation expertise.
• Regulatory lifecycle management experience.
• Strong communication and coordination skills.
• Attention to detail and compliance-focused approach.

How to Apply

Interested candidates can send their updated resume to:

📧 hr@clapspharma.com

Technical FAQs

1. What is a CTD and eCTD dossier?

CTD (Common Technical Document) is a standardized format used for regulatory submissions, while eCTD is its electronic version accepted by many global regulatory authorities for faster review and tracking.

2. What are ROW markets in Regulatory Affairs?

ROW (Rest of World) markets refer to international countries outside major regulated markets such as the US, EU, and Japan. Regulatory requirements vary by country and require customized submissions.

3. Why is regulatory dossier review important?

Dossier review ensures that product quality, safety, efficacy, and manufacturing information meet regulatory requirements before submission and approval.

4. What is regulatory lifecycle management?

It involves managing product registrations after approval, including renewals, variations, amendments, and compliance updates throughout the product’s commercial life.

5. What is the role of CAPA in Regulatory Affairs?

CAPA (Corrective and Preventive Action) helps identify compliance issues, implement corrective measures, prevent recurrence, and maintain regulatory and quality standards.