Work in Regulatory Affairs at Hetero Drugs Ltd
Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. Backed by over 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Generics, Biosimilars, Custom Pharmaceutical services and Branded Generics.
Post : Regulatory Affairs
• To verify the country specific guidelines, evaluate & submit the dossiers as per the client/MOH requirements.
• To prepare the dossiers (eCTD, CTD & country specific format) that review, organization for AFRICAN, CIS, LATAM and MENA region countries.
• Receipt and submission of responses to the queries of dossier of data packages submitted to AFRICAN, CIS, LATAM and MENA countries.
• To co-ordinate with cross functional teams to initiate the new studies for suffice the query response & dossier requirement towards country specific requirements for product registration.
• To prepare & submission of post approval changes (PAC) in accordance with country specific variation guidelines & get the approvals.
• Keeping abreast with updating of country specific regulations and guidance.
• To co-ordinate with CFTs for preparation of Master Artworks.
Desired Skills and Experience : Ctd , Latam , Clinical Research , Regulatory Affairs , Pharma , Cis.
Experience : 10-13 years
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