Executive / Officer - Regulatory Affairs

1 month ago


Gurugram Haryana, India Coral Drugs Full time

Posted:
September 2024

**Key Responsibilities**:

- Compilation, preparation, and review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS or CTD formats.
- Setting specifications of API process development, knowledge of litigation related to Drugs and Cosmetics Act.
- Filing annual updates and amendments to various regions of submitted DMFs.
- Handling queries obtained from different regulatory agencies and customers.
- Compilation, preparation and review of Technical Package of API's.
- Compliance to audits of regulatory bodies especially USFDA and EU.
- Generation of documents from R&D, Production, QC and QA of newly developed API's.

**Administrative Duties**:

- Responsible for record keeping and to ensure correctness of records pertaining to department.
- Responsible for all type of computer work and follow-ups.
- Carrying out the initial assessment of Vendor Questionnaire and relevant documents.
- Maintain housekeeping and cleanliness of plant.
- To impart scheduled trainings of ICH guidelines pertaining to department.

**Job Requirements**:

- ** Desirable**: Minimum 03 to 05 years working experience B. Pharma/M. Pharma
- ** Location**: Murthal, Sonipat.


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