Greetings from Hetero Biopharma…!!!
We are following positions in Production & Regulatory Affiars departments.
Department: Production Compliance
Position: Jr. Officer/ Officer
Qualification: B.Pharmacy/ M.Pharmacy/ M.Sc
Experience: 1 – 3 years production compliance with Formulation (OSD) Experience only.
Job Location: Jeedimetla (Hyderabad)
Interested candidates may share their profile to Bhagyalakshmi.email@example.com
Department: Regulatory Affiars
Designation: Sr. Executive/Assistant Manager
Experience: 4 – 9 years of experience
- 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.
Interested candidates may share their profile on firstname.lastname@example.org