Regulatory Affairs Officer
4 days ago
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
- 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
Pay: ₹10,000.00 - ₹15,000.00 per month
**Benefits**:
- Flexible schedule
Schedule:
- Day shift
Supplemental Pay:
- Yearly bonus
Work Location: In person
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