Senior Regulatory Affairs Trainer

3 weeks ago

Guntur, India Tek Support Full time

Job Title: Regulatory Affairs

Location: Remote

Job type: Part-time


Job Summary:

We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance , submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible for designing and delivering advanced training programs that equip professionals with the knowledge and skills required to manage complex regulatory processes , ensure compliance with international standards, and handle audits effectively.


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.

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