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.
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).