Senior Regulatory Affairs Trainer

Job Title:

Location:

Job type:

Job Summary:

Regulatory Affairs Trainer

Key Responsibilities:

• Develop and deliver comprehensive training modules on

  regulatory submissions,

  including

  IND, NDA, ANDA, 510(k), PMA, CE Marking, and country-specific registrations

  .
• Provide hands-on training in

  FDA, EMA, ISO 13485, ICH, and country-specific regulatory compliance

  .
• Train teams on

  labeling review and artwork compliance

  to meet global standards.
• Educate participants on

  regulatory strategy and lifecycle management

  for products, including renewals, variations, and

  post-market surveillance

  .
• Conduct training on

  audit preparation, mock inspections, and CAPA (Corrective and Preventive Actions)

  .
• Develop case studies and practical exercises on

  regulatory risk assessment

  and submission dossier preparation (CTD/eCTD format).
• Collaborate with cross-functional teams to align training content with

  quality, manufacturing, and R&D requirements

  .
• Mentor junior regulatory professionals on industry best practices and career development.
• Maintain up-to-date knowledge of

  global regulatory changes

  and incorporate them into training programs.
• Provide

  post-training assessments

  , feedback, and continuous improvement of training materials.

Required Skills & Expertise:

• 10+ years of experience

  in Regulatory Affairs in medical devices, pharmaceuticals, biotech, or FMCG.
• Proven expertise in

  regulatory submissions

  (IND/NDA/ANDA, 510k, CE Marking, PMA).
• Strong understanding of

  FDA, EMA, ISO 13485, ICH, GxP, and other global regulations

  .
• In-depth knowledge of

  labeling compliance

  , product registrations, renewals, and lifecycle management.
• Experience in

  audit management, regulatory inspections, and remediation planning

  .
• Excellent communication, presentation, and mentoring skills.
• Ability to simplify complex regulatory concepts for diverse audiences.

Preferred Qualifications:

• Master’s degree in Pharmacy, Biotechnology, Life Sciences, or Regulatory Affairs (preferred).
• RAC (Regulatory Affairs Certification) or equivalent professional certification.
• Experience training or mentoring regulatory professionals in corporate or consulting settings.