Recruitment in DRA and Production at Hetero Biopharma

The leading edge of Hetero Group, Hetero Biopharma, is steadily establishing itself as a path breaking Biosimilar developer. As a strong R&D driven company offering some of the blockbuster Biosimilar Drugs, we at Hetero Biopharma are bringing about a paradigm shift in the way patients suffering from various chronic conditions are treated.
As a part of the Hetero Group, our Biologics vertical, comes with a rich legacy - Proven capabilities in the development, manufacturing and marketing of chemical intermediates, APIs, ARVs and Finished Dosage Formulations. With leadership in chemical therapeutics, Hetero continues to lead from the front in the development and manufacturing of Biopharmaceuticals using novel technologies. Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide. And a majority of our facilities have been successfully audited and approved by stringent regulatory authorities like US FDA, EU, TGA-Australia, MCC-South Africa and others. Our portfolio includes 300 plus products encompassing major therapeutic categories such as HIV/AIDS, Oncology, Cardiovascular, Neurology, Hepatitis, Nephrology, Urology, Diabetes, Ophthalmology, Hepatology and Immunology etc.

Opening For Production Compliance Position
Hiring for Production Compliance position with Formulation (OSD) Experience only.
Department: Production Compliance
Post: Jr. Officer/ Officer
Experience: 1 to 3 yrs
Job Location: Jeedimetla (Hyderabad)
Qualification: B.Pharmacy/M.Pharmacy/M.Sc
Interested candidates forward their resumes to Bhagyalakshmi.bu@heterodrugs.com

Opening For Regulatory Affairs Position
Department: Regulatory Affairs
Post: Sr. Exe / Asst. Mgr
Experience: 4 Yrs to 9 Yrs
Job Location: Jadcherla (Telangana)
1. To verify the country specific guidelines, evaluate & submit the dossiers as per the client/MOH requirements.
2. To prepare the dossiers (eCTD, CTD & country specific format) that review, organization for AFRICAN, CIS, LATAM and MENA region countries.
3. Receipt and submission of responses to the queries of dossier of data packages submitted to AFRICAN, CIS, LATAM and MENA countries.
4. 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.
5. To prepare & submission of post approval changes (PAC) in accordance with country specific variation guidelines & get the approvals.
6. Keeping abreast with updating of country specific regulations and guidance.
Interested Candidates share profile to edukondalu.m@heterodrugs.com

Additional Information
Experience : 1-9 years
Department : Production, DRA
Location : Jeedimetla, Jadcherla (Telangana)
Industry Type : BioPharma
End Date : 30th June, 2020

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