Regulatory Affairs Executive / Sr. Executive

Zenzi Pharmaceutical Industries; Mumbai; On-site; INR 3,000,000 - 4,600,000; Full time

Job summary

Zenzi Pharmaceutical Industries in Mumbai seeks a highly experienced Regulatory Affairs professional with a deep background in ROW and EU markets. You will drive dossier preparation, eCTD submissions, and cross-functional coordination for regulatory submissions and compliance across multiple countries.

The role requires hands-on experience with CTD/eCTD structures, lifecycle management, and effective handling of deficiency responses.

Qualifications

• Extensive hands-on experience with EU and ROW regulatory requirements.
• Proven track record in eCTD submissions and publishing.
• Strong lifecycle management knowledge.
• Familiarity with CTD/eCTD structure and country guidelines.
• Experience handling regulatory queries and deficiency responses.
• Excellent communication and cross-functional coordination.
• Ability to manage multiple dossiers within deadlines.

Responsibilities

• Prepare, compile, review, and submit regulatory dossiers for ROW and EU markets in CTD/eCTD formats.
• Handle registrations, renewals, variations, and post-approval submissions.
• Work with eCTD software/tools and submission management.
• Prepare Module 1 to Module 5 documents per country guidelines.
• Manage lifecycle activities including variations, renewals, and artwork updates.
• Coordinate with QA, QC, Production, Packaging Development, and R&D.
• Track submission timelines and maintain regulatory databases.
• Review labeling materials, SmPC, PIL, and artwork for compliance.
• Liaise with agents/distributors and regulatory authorities.
• Stay updated on regulatory guidelines for EU and ROW.
• Support dossier gap analysis and deficiency management.

Skills

EU regulatory requirements

ROW regulatory requirements

eCTD submissions

Lifecycle management

CTD/eCTD structure

Regulatory queries & deficiency      

Tools

eCTD software

Job description

We are seeking a motivated and detail-oriented Regulatory Affairs professional with 25 years of experience in ROW and EU markets. The candidate should have hands-on experience in dossier preparation, eCTD submissions lifecycle management activities, and coordination with cross-functional teams for regulatory submissions and compliance activities.

Key Responsibilities

• Preparation, compilation, review, and submission of regulatory dossiers for ROW and EU markets in CTD/eCTD formats.
• Handling new registrations, renewals, variations, responses to deficiency queries, and other post-approval submissions.
• Expertise in eCTD software/tools and electronic submission management.
• Preparation and review of Module 1 to Module 5 documents as per country-specific guidelines.
• Lifecycle management activities including variations, renewals, notifications, amendments, artwork updates, and product name changes.
• Coordination with internal departments such as QA, QC, Production, Packaging Development, and R&D for regulatory documentation.
• Tracking submission timelines and maintaining regulatory databases/document trackers.
• Reviewing and ensuring compliance of labeling materials, SmPC, PIL, and artwork as per regulatory requirements.
• Coordination with agents/distributors and regulatory authorities for submission-related activities and query responses.
• Keeping updated with changing regulatory guidelines and market requirements for EU and ROW countries.
• Support in dossier gap analysis and document deficiency management.

Required Skills & Competencies

• Good knowledge of EU and ROW regulatory requirements.
• Hands-on experience in eCTD submissions and publishing tools.
• Strong understanding of lifecycle management activities.
• Knowledge of CTD/eCTD structure and submission processes.
• Experience in handling regulatory queries and deficiency responses.
• Good communication, coordination, and documentation skills.
• Ability to manage multiple projects within timelines.

Proficiency in Microsoft Office applications