Drug Regulatory Affairs Specialist

ABOUT THIS ROLE

We are an AI company building tools for pharmaceutical regulatory affairs — specifically for compiling, reviewing, and managing regulatory dossiers. Our AI helps assemble CTD modules, check completeness of submission packages, and flag gaps before filing. We need regulatory affairs professionals who have personally submitted dossiers to health authorities and can tell us from experience what the AI gets right and what it misses.

WORKFLOWS COVERED

• eCTD dossier compilation — Module 1 (administrative), Module 2 (summaries), Module 3 (quality), Module 4/5 (nonclinical and clinical)
• New Drug Application (NDA), Abbreviated NDA (ANDA), Marketing Authorisation Application (MAA) submissions
• Product variation and lifecycle management — Type I/II variations, labelling updates, renewals
• Health authority query responses and deficiency letter management

WHAT YOU WILL DO

• Share how regulatory submissions and dossier management work in practice — the compilation process, health authority expectations, and the realities of managing deficiencies and timelines
• Review regulatory documents, dossier structures, or submission checklists and tell us where they miss what a real regulatory affairs professional would flag
• Help us understand the practical differences across regulatory environments — CDSCO, FDA, EMA — from someone who has filed to at least one of them
• Advise on what good regulatory operations look like and where common gaps arise in the submission and lifecycle management process

YOU ARE THE RIGHT FIT IF

• Minimum 3 years in regulatory submissions or regulatory affairs — hands-on dossier work, not just regulatory strategy
• Have personally compiled eCTD modules, filed applications, or managed product registrations for at least one health authority
• Know the difference between NDA and ANDA, Type IA and Type II variations, and PAS vs CBE-30 from real work
• Worked at organisations such as Sun Pharma, Dr Reddy's, Cipla, Lupin, IQVIA, Parexel, or a regulatory consulting firm

NICE TO HAVE

• RAC certification (Regulatory Affairs Certification — RAPS)
• Experience with CDSCO (India) submissions specifically
• ICH M4 CTD structure knowledge from having built dossiers to it — not just read about it