Responsible to prepare and review of dossier as per CTD / ACTD / Country specific guidelines
Responsible for dossier compilation and query response
Co-ordination with Cross-Functional Team and Business Partners
To prepare and review all technical documents (SPEC, BMR, MFR, Validation reports etc)
Proficiency in literature search for products at various stage of R&D.
Ability to conduct secondary research and acquire information from internet sources, journals, public databases, etc.
Experienced and good hand-on drafting Clinical & non-clinical overview/summary.
Required knowledge of toxicity studies, BA-BE studies and clinical trials.
Working on regulatory agencies regarding
Pre-submission strategies, potential regulatory pathways.
Review of documents to ensure there are no gaps
Maintains the highest level of submission standards.
Maintains familiarity with evolving and/or new regulatory e-submission requirements maintains the highest level of submission standards.
Maintains familiarity with evolving and/or new regulatory e-submission requirements
Familiarization with evolving guidance of Row markets
Job Type: Full-time
Jadwal:
Education:
Experience:
- total work: 1 year (Preferred)
Work Location: In person
