USV Pvt Ltd is looking to hire Executive – Regulatory Affairs – Solid Orals .Interested and eligible candidates can send their resume…We are a leading health care company with the following areas of focus: Branded Generics, Active Pharmaceutical Ingredients (APIs &amp; Formulation) and Bio-similars. Sixty-eight percent of our business is contributed by the India operations and the rest by export of APIs &amp; Formulations and Branded generics…..The eligibility criteria as follows.
Vacancy details :
|Company Name||: USV Pvt Ltd|
|Designation||: Executive – Regulatory Affairs – Solid Orals|
|No. of Vacancies :||:NA|
|Location||:Mumbai( Govandi )|
|Salary||: Not Disclosed|
- Submission of controlled correspondence to USFDA for IID Limits, stability study design, BE study design, RLD designation etc.
- Co-ordinate, Collate and Conduct review of relevant standard technical documentation like specification, stability, PDR, method validations, BMR, BPR as per the USFDA requirements.
- Compilation of high quality dossier in line with the current requirement of USFDA for various solid oral dosage forms specifically IR Tablets, MR Tablets, Capsule dosage forms.
- Assist in resolution of queries / deficiency received from customer / USFDA, and timely submission of response to query /deficiency.
- e-CTD compilation/ publishing of Dossiers and Submission to customer / USFDA.
- Preparation and review of labeling/artwork/SPL .
- Review and regulatory impact analysis of the changes notified by the vendors as well as evaluate any changes proposed post-approval. Prepare and file necessary amendments / supplements / annual reports as applicable with USFDA to ensure regulatory compliance (Post-approval Life Cycle Management).
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