Senior Executive Regulatory Affairs Europe

Key Responsibilities

Regulatory Submissions & Dossier Compilation

• Compile, review, and maintain regulatory dossiers in

  eCTD/CTD format

  for submissions to

  European regulatory authorities

  .
• Prepare and manage

  Modules 15

  , with strong expertise in quality (CMC) documentation.
• Support

  new marketing authorization applications

  via

  Centralised, DCP, MRP, and National procedures

  .
• Ensure submissions are compliant with

  EMA, EU directives, and guidelines

  .

Post-Approval & Lifecycle Management

• Manage

  post-approval variations

  (Type IA, IB, II), renewals, line extensions, and notifications.
• Handle

  responses to regulatory queries

  , deficiency letters, and commitments within defined timelines.
• Maintain

  product licenses

  and ensure regulatory compliance throughout the product lifecycle.
• Track and implement

  regulatory changes and updates

  impacting registered products.

Regulatory Compliance & Coordination

• Liaise with

  cross-functional teams

  (Quality, R&D, Manufacturing, Pharmacovigilance) to gather and align regulatory documentation.
• Coordinate with

  EU affiliates, partners, and consultants

  for submissions and approvals.
• Ensure adherence to

  data integrity, documentation standards, and SOPs

  .

Documentation & Systems

• Maintain regulatory databases, submission trackers, and archival systems.
  
• Prepare and review

  regulatory summaries, reports, and internal communications

  .
• Support audits and inspections related to regulatory documentation.
  

Skills & Competencies

• Strong knowledge of

  EU regulatory framework and procedures

• Hands-on experience in

  dossier compilation and lifecycle management

• Proficiency in

  eCTD publishing and regulatory submission tools

• Good understanding of

  CMC, quality, and regulatory compliance requirements

• Ability to interpret and apply

  EMA guidelines and EU legislation

• Strong coordination, documentation, and time-management skills
  
• Attention to detail with a compliance-focused mindset