Senior Regulatory Affairs Executive -ROW (Formulation)

Department:

Role Summary

The RA-ROW Sr. Executive will be responsible for preparing, reviewing, and submitting regulatory dossiers for Rest of World (ROW) markets, ensuring compliance with country-specific regulatory requirements. The role requires strong coordination with cross-functional teams in Manufacturing, QA, QC, R&D, Packaging Development, and SCM to support product registrations, renewals, and post-approval lifecycle management.

Key Responsibilities

1. Dossier Preparation & Submission

• Prepare, compile, and review regulatory dossiers in CTD/eCTD / ACTD formats for ROW markets (Africa, Asia, CIS, LATAM, Middle East, etc.).
  
• Ensure dossiers meet country-specific guidelines and regulatory expectations.
  
• Coordinate with internal teams to ensure completeness, accuracy, and timely availability of required documents.
  

2. Product Registration & Approvals

• Manage end-to-end product registration processes and follow up with regulatory authorities/agents.
  
• Respond to regulatory queries, deficiency letters, and clarifications in a timely manner.
  
• Track and maintain status of submissions, approvals, and renewals.
  

3. Lifecycle Management

• Handle post-approval changes (PACs) such as variations, renewals, line extensions, and label updates.
  
• Maintain up-to-date product regulatory dossiers and ensure compliance with evolving regulations.
  

4. Labeling & Artwork Compliance

• Review and approve artworks, labels, and packaging components to ensure regulatory alignment.
  
• Prepare and update product information (PIL/Smar, SmPC, insert updates).
  

5. Cross-Functional Coordination

• Engage with QA, QC, R&D, Production, Packaging, SCM, and other teams for data collection and dossier updates.
  
• Support product development teams with regulatory guidance during new product initiation (NPI).
  

6. Regulatory Intelligence

• Monitor changes in regulatory guidelines in ROW markets and communicate updates internally.
  
• Maintain knowledge of global regulatory trends and competitor regulatory activities.
  

7. Documentation & Compliance

• Ensure adherence to regulatory SOPs, quality guidelines, and company systems.
  
• Maintain databases, trackers, and documentation as per internal and external audit requirements.
  

Key Skills & Competencies

• Strong understanding of CTD/ACTD formats and ROW regulatory requirements.
  
• Experience in handling regulatory submissions for ROW markets is mandatory.
  
• Excellent documentation, reviewing, and communication skills.
  
• Ability to work effectively with cross-functional teams.
  
• Attention to detail and strong organizational skills.
  
• Proficiency in regulatory software/tools and MS Office.
  

Qualifications

• M. Pharm

• Experience:

  4–8 years

  in Regulatory Affairs (ROW submissions) within the pharmaceutical industry.

Preferred Experience

• Experience with injectable formulations, oncology products, or complex generics.
  
• Previous exposure to African, Southeast Asian, LATAM, or CIS country submissions.
  
• Knowledge of GMP and international regulatory frameworks.

Regards

Team Jodas Expoim Pvt ltd