ACME Group
Website:
acmegenerics.in
Job details:
Markets: ROW & emerging markets
Role: Assistant Manager
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
- Strong time management and emotional intelligence
Click on Apply to know more.