Regulatory Affairs Executive

2 months ago

Panvel, India Ultratech India Ltd. Full time

Preparation of API DMF for regulated markets
- Thorough experience of preparation of DMFs, filing for COS / CEP /EDQM
- Thorough Awareness of updated regulatory guidelines for registration of products in EU, ANVISA, Ukraine, UK, Japan, Philippines, Russia
- Capability to prepare DMF without much of support from Production / QC departments
- Preferable if the person has worked in QC at some time with experience on HPLC
- Good exposure on interpreting Organic chemistry & analytical results.
- Preparation of Formulation Dossiers in eCTD formats for regulated markets
- Thorough Awareness of updated regulatory guidelines for registration of products in EU, ANVISA, Ukraine, UK, Japan, Philippines, Russia
- Capability to prepare eCTD Dossiers without much of support from Production / QC departments
- Preferable if the person has worked in QC at some time with experience on HPLC
- With past knowledge of preparing pMDIs dossiers

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹200,000.00 - ₹450,000.00 per year

**Benefits**:

- Leave encashment

Schedule:

- Day shift

Supplemental pay types:

- Overtime pay
- Yearly bonus

**Speak with the employer**
+91 9819132203

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