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Lupin Limited is one of India’s largest manufacturers of bulk actives and formulations. The principal bulk actives manufactured by it include Rifampicin, Pyrazinamide, Ethambutol (anti-TB), Cephalosporins (anti-infectives) and cardiovasculars. The company also possesses competencies in phytomedicines, in which medicines are made out of plant and herbal resources supported by the discipline of modern medicine.
Job Title : Officer / Executive – Regulatory Affairs
Location : Visakhapatnam
Qualification : MS/M.Sc(Science) – Bio-Chemistry, Chemistry, Microbiology, Organic Chemistry, B.Pharm
Experience : 1-5 Yrs preferably from RA/QA in API with relevant experience
Job requirement:
- Review of documents for DMF submissions to advanced market,
- knowledge of QA systems like Change Control, Deviations ,PVR, BPR Approval,
- Specifications approval, stability etc.
- Knowledge on regulatory requirements and Compliance
Skills required : Good communication and negotiation skills