The ideal candidate should hold solid expertise in the following areas:
Technical Skills:
Good grasp of pharma regulatory practices, CMC, ICH guidelines, and market specific requirements (Asia, LATAM and Africa)
Experience in dossier gap assessment
Proven authoring capabilities in CTD and ACTD formats (Modules 1, 2, and 3)
Ability to draft well-reasoned responses to client and authority queries
Familiarity with ROW market-specific regulatory expectations.
Soft Skills:
Excellent communication and writing abilities
Collaborative, adaptable, and proficient in multitasking
Solid time management and emotional intelligence