Work in Regulatory Affairs at Hetero Drugs Ltd

Pharma Admission

Pharma courses

pharma admission

pharma courses

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

Job Description
• 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

Interested Candidates share profile to

See All   B.Pharm Alerts   M.Pharm Alerts    Ph.D Alerts   Delhi Alerts

See All   Other Jobs  in our Database

Subscribe to Pharmatutor Job Alerts by Email