Senior Regulatory Affairs Trainer

Job Title:Regulatory Affairs Location:Remote Job type:Part-timeJob Summary: We are seeking a highly experiencedRegulatory Affairs Trainerwith over 10 years of expertise inglobal regulatory compliance , submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible fordesigning and delivering advanced training programs that equip professionalswith the knowledge and skills required to managecomplex regulatory processes , ensure compliance with international standards, and handle audits effectively.Key Responsibilities: Develop and deliver comprehensive training modules onregulatory submissions,includingIND, NDA, ANDA, 510(k), PMA, CE Marking, and country-specific registrations . Provide hands-on training inFDA, EMA, ISO 13485, ICH, and country-specific regulatory compliance . Train teams onlabeling review and artwork complianceto meet global standards. Educate participants onregulatory strategy and lifecycle managementfor products, including renewals, variations, andpost-market surveillance . Conduct training onaudit preparation, mock inspections, and CAPA (Corrective and Preventive Actions) . Develop case studies and practical exercises onregulatory risk assessmentand submission dossier preparation (CTD/eCTD format). Collaborate with cross-functional teams to align training content withquality, manufacturing, and R&D requirements . Mentor junior regulatory professionals on industry best practices and career development. Maintain up-to-date knowledge ofglobal regulatory changesand incorporate them into training programs. Providepost-training assessments , feedback, and continuous improvement of training materials.Required Skills & Expertise: 10+ years of experiencein Regulatory Affairs in medical devices, pharmaceuticals, biotech, or FMCG. Proven expertise inregulatory submissions(IND/NDA/ANDA, 510k, CE Marking, PMA). Strong understanding ofFDA, EMA, ISO 13485, ICH, GxP, and other global regulations . In-depth knowledge oflabeling compliance , product registrations, renewals, and lifecycle management. Experience inaudit 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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