Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs.
- Vacancy details:
- Department:Regulatory Affairs-API
- Qualification:MS/M.Sc(Science),M.PharmaÂ
- Experience:2 to 7 year(s)
Job Description –: Greeting from Hetero Drugs Limited!!!!
Important Details :
- Location: Hyderabad
- Post of date:11/09/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Job Description
Role & responsibilities
Compilation, review and submission of Drug master files (Module1, 2 & 3) as per CTD format.
• Compilation and Submission of Post approval changes and Life cycle management of DMF with appropriate CMC documentation.
• Addressing the responses to queries received from various customers. • Change control management and customer notifications.
• Inclusion of nitrosamine and genotoxic impurities information in DMF as per the assessment reports.
• Preparation of Letter of access, Declaration of access and Letter of commitments to US, EU, Australia and ROW markets as per customer requirements
• Preparation of Regulatory and Non regulatory documents like technical packages, Applicants Part & Restricted parts of DMF.
• Periodic updates of USDMF [Amendment and Annual reports], EDQM (Minor and major changes notifications)
• eCTD submissions (Pharma ready) to regulatory authorities.
Interested Candidates Please Share Your updated Resume @ vivek.s@hetero.com
