Unichem Laboratories Released Job Openings On 20/06/2022.Promoted by the late Mr. Amrut Mody, a pioneer of the Indian pharmaceuticals business, Unichem Laboratories has grown to become one of India’s most respected pharmaceutical companies. It is committed to deliver better health through superior products.
Unichem Laboratories Recruiting B.Pharma,M.Pharma Candidates with 06 – 10 years of Experience for Research Executive / Sr. Research Executive Clinical Research Position.Complete Details for the Research Executive / Sr. Research Executive Clinical Research as follows.
Important Details :
- Location : Goa
- No of Vacancies:01
- Details of Salary: NA
- Opening date for online Application: 20/06/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Related Job : Alkem Laboratories looking For FRESHERS And Experienced
Job Description/Skills Required
- e-CTD submission of Module 5 as per CDISC requirement, section 2.5 clinical overview and section 2.7 Clinical summary of Dossier for USFDA, Europe regulatory authorities by using Educe / “Pharma ready” software.
- Handle BE clinical, eCTD regulatory queries & deficiency.
- Handle in ICH – GCP guidelines for conduction of Bioequivalence studies & Clinical trials.
- Design Bioequivalence studies for various therapeutic categories.
- BE Protocol preparation for different study designs as per regulatory requirement.
- Perform evaluation of PK data obtained from BA/BE studies.
- Auditing & monitoring of CRO (clinical & Bioanalytical).
- Perform review of BE CRF, clinical & Bio-analytical reports for ANDA /EU / ANVISA/ ROW submission.
- Preparation of section 2.5 clinical overview and section 2.7 Clinical summary” of Dossier for USFDA, Europe submission.
- Develop SOPs for BE operations and handle BTIF for regulatory submission.
- Study report preparation and filling in coordination with regulatory affairs department
- Handle BE clinical & bioanalytical regulatory queries & deficiency.
- Handle toxicity studies for bulk drug & impurities.