Coral Drugs, headquartered in New Delhi, India, is an integrated, research-based international pharmaceutical company that produces a wide range of high-quality, affordable active drug ingredients. With a team of dedicated scientists, Coral's R&D department provides efficient processes for off-patent products. Our goal is to maximize on the production of active ingredients by discovering new ways to manufacture, without compromising quality. Having clients all over the world, we assume a great level of corporate responsibility. Adhering to quality production standards across the globe, Coral Drugs takes pride in being a true international supplier of high-quality pharmaceuticals.
Post : Asst.Manager/Sr. Executive: Regulatory Affair
Job Description:
• Prepare and review regulatory submission for regulated, Semi regulated and row markets.
• Drafting and Compilation of documents for preparation of dossiers and handling related queries.
• Hands on experience of CTD, ACTD and country specific dossiers.
• Responding to queries within scheduled timelines.
• Co-ordination and follow ups with all functional departments.
• Review of pharmaceuticals Development Report (PDR), Manufacturing and validation documents, (QSD) Quality Standard Documents, (COA) Certificate of Analysis.
• Experienced in API Drug Master File creation and filings in regulatory and non-regulatory markets.
Additional Information:
Experience: 3-5 years
Location: Sonipat
Education: M.Sc. /B.Pharm/M. Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Send your application to hrd@coraldrugs.com
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