Hetero Drugs 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.
Education:
MS/M.Sc(Science) in Organic Chemistry, Chemistry, M.Pharma in Pharmacy
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-HRRole:
OtherIndustry Type:
Pharmaceutical & Life SciencesDepartment:
OtherEmployment Type:
Full Time, PermanentRole Category:
Other
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