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USV Pvt Ltd Hiring For Executive – Regulatory Affairs – Solid Orals

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 & Formulation) and Bio-similars. Sixty-eight percent of our business is contributed by the India operations and the rest by export of APIs & Formulations and Branded generics…..The eligibility criteria as follows.

Vacancy details :

Company Name : USV Pvt Ltd
Department :Regulatory Affairs
Designation : Executive – Regulatory Affairs – Solid Orals
No. of Vacancies : :NA
Location :Mumbai( Govandi )
Qualification :Graduate 
Experience :03-06+
Salary : Not Disclosed

 

Job description:-.

  • 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).

How to Apply :  Click here for full details and Apply

Author: Niranjan Reddy

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