Regulatory Affairs Officer/Executive

Role & responsibilities:

To support and manage regulatory submissions, product registrations, and lifecycle maintenance activities in compliance with global regulatory requirements, ensuring timely approvals and sustained market authorization of pharmaceutical and life science products.

Key Responsibilities

• Prepare, review, and submit

  regulatory dossiers (CTD / eCTD)

  for regulated and semi-regulated markets
• Handle

  product registrations, renewals, variations, and amendments

• Compile and maintain

  CTD Modules 15

  as per regulatory guidelines
• Respond to

  regulatory authority queries, deficiency letters, and commitments

  within defined timelines
• Coordinate with

  QA, QC, R&D, Production, Packaging, and Pharmacovigilance

  teams for regulatory inputs
• Review and approve

  labeling, artwork, package inserts, SmPC, and IFUs

  for regulatory compliance
• Support

  post-approval change management

  and regulatory impact assessments
• Prepare and maintain

  Drug Master Files (DMF), Site Master Files (SMF), and ASMFs

• Review

  stability study data

  and support regulatory submissions
• Provide regulatory support during

  audits, inspections, and client interactions

• Track regulatory submissions and approvals using internal systems
• Ensure compliance with

  data integrity, GDP, and document control

  practice
• Monitor

  regulatory intelligence

  and guideline updates

Technical Skills

• Strong knowledge of

  CDSCO, WHO-GMP, ICH, USFDA, EMA

  regulations
• Hands-on experience with

  CTD / eCTD submissions

• Knowledge of

  post-approval changes & lifecycle management

• Understanding of

  pharmacovigilance reporting requirements

  (basic)
• Familiarity with

  eCTD publishing tools

  and regulatory databases

Behavioral Skills

• Excellent attention to detail
• Strong written & verbal communication skills
• Time management and multi-tasking ability
• Problem-solving and regulatory risk assessment
• Ability to work independently and in cross-functional teams