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
- Qualification: MSC/M. Pharm/B. Pharm
- Experienced: 2Â –Â 7Â years
Job Description: Greeting from Hetero Drugs Ltd!!!!
Important Details :
- Location : Hyderabad
- Post of date 08/10/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Job description
Department: Regulatory Affairs-API
Industry Type: Pharma Only
Experience: 2 to 8 Years
Qualification: MSC/M. Pharm/B. Pharm
Location: Hyderabad
Role & responsibilities
Compilation of DMF for different Regulatory Agencies (USFDA, EDQM, China, Brazil, Europe and other regulatory markets) in eCTD format based on the requirement.
• Preparation of amendments/updates/annual updates for the drug master files as per schedule.
• Compilation of the open part, restricted parts of DMFs and technical packages based on customer requirement.
• Issuing LOAs based on customer request and responsible for handling of the queries from the different Regulatory Agencies.
• Basic knowledge about Organizations registrations through SPOR – OMS – EMA
• Customer support for the queries on Drug master files.
• Coordinating with cross functional Teams for collection and interpretation of data required for DMF submissions.
• Assist and coordinate with reporting manager for submission of documents to agencies.
• Evaluation of change controls against to the current guidelines.
• Coordinating with QA during the customer audits and regulatory audits.
• Ensure on-going update for DMF tracker, customer queries, LoA, Submission, Courrier and CCF tracker.
• Ensure good practices are followed at archival.
• Continues knowledge update and self-improvement in all the guidelines
Interested Candidates Share Your Updated Resume At vivek.s@hetero.com
Thanks & Regards
vivek.s-HR
