Sr Executive Regulatory Affairs (Europe Market)

Designation:

Job Purpose

To manage regulatory submissions, approvals, and lifecycle maintenance of pharmaceutical products for the European Union market, ensuring compliance with EU regulatory requirements, EMA guidelines, and company timelines.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers in

  CTD / eCTD format

  for EU registrations (DCP, MRP, and National Procedures)
• Coordinate with internal departments (R&D, QA, QC, Manufacturing, Packaging) for regulatory data and documentation
  
• Liaise with EU agents, MAHs, partners, and regulatory consultants for submissions and approvals
  
• Track submissions, approvals, and respond to

  EMA / National Competent Authority (NCA)

  queries
• Ensure regulatory compliance with

  EU GMP, ICH, EMA, CMDh, and national regulations

• Review and approve artwork and labeling changes in line with EU requirements
  
• Maintain regulatory databases, submission trackers, and archival systems
  
• Monitor updates in EU regulatory guidelines and assess impact on existing products
  
• Support audits, inspections, and regulatory intelligence activities
  

Required Skills & Competencies

• Strong knowledge of

  EU regulatory procedures and guidelines

• Familiarity with

  eCTD publishing and validation requirements

• Strong documentation, coordination, and communication skills
  
• Ability to handle multiple dossiers and tight regulatory timelines
  
• Proficiency in MS Office and regulatory tracking tools
  

Educational Qualification

• Bachelors or Master’s degree in Pharmacy, Pharmaceutical Sciences, or related discipline
  

Experience

• 4–8 years of experience in

  EU Regulatory Affairs

• Practical experience in dossier preparation, submissions, and post-approval activities
  

Preferred Attributes

• Exposure to multiple dosage forms (oral solids, injectables, topical, etc.)
  
• Knowledge of pharmacovigilance and quality systems is an advantage
  
• Ability to work independently and in cross-functional teams