Hetero Drugs Limited Released Job Openings On 07/03/2022. Hetero Drugs Limited is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.Interested and eligible candidates can submit application along with resume.
Vacancy Details:
Hetero Drugs Limited Recruiting Msc,B Pharm,M Pharm with 2-10years experience for Regulatory Affairs Department.Complete Details for the Regulatory Affairs as follows.
Important Details :
- Location : Hyderabad
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: NA
- Opening date for online Application: 07/03/2022
- How To Apply: Desired Candidates Share Your Profile At Vivek.S@heterodrugs.com
Related Job : Hetero FRESHERS Walk In On 8th March 2022
Job Description/Skills Required
- Responsible for the preparation and meticulous review of all pertaining technical documents required for USFDA filings especially Module- 2, 3 and 5 in e-CTD format.
- Responsible for preparation and review of Batch production control records, stability protocols, submission protocols, Submission batch summary reports, stability data and stability reports for ANDA submission batches.
- Responsible for Support regulatory affairs activities in ANDA filings
- Responsible to support technical data for ANDA filings and Responsible for support to address responses for query from customers and regulatory agency.
- Responsible for review of change controls and deviations and their assessments required for submission batches and to address the responses from customers and regulatory agency.
- Coordinate with concerned departments like Quality Control, Quality Assurance, Manufacturing and Research Development for compilation of technical data for dossiers and meet the submission timelines.
- Review of Technical documents Like Product development report, APR , API Tech packages/ASMFs/DMFs,
- Responsible for preparation and review of Post approval stability protocols and annual report and its supplements.
- Review of documents like API, In-Process, Finished Product and Excipients and packing material specifications and STPs.
- Review of documents like process validation protocols and reports.
- Review of stability study protocols and reports (Long term, Intermediate, Accelerated).
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