krishna kotaru

hetero labs limited

About

Professional with 14.3 years of rich experience in Global Regulatory Submissions and Quality Assurance of Active Pharmaceutical Ingredients. Areas of excellence includes: -Global Regulatory Affairs -Customer Support -Change management -Process Improvement -Technology Transfers -Quality Management & Compliance -Exposure to Global Regulatory Submissions -Exposure to Global Inspections - Regulated markets (USFDA, MHRA, DMA, TGA, PMDA) - Emerging markets(KFDA, Chinese FDA, IN) - Others( ISO, WHO, USP) Specialties: Regulatory Submissions in EU, US, Japan, Canada and Near Regulatory markets. CMC write up, Change management, Regulatory deficiencies response, Regulatory Compliance & Customer support.

Country

india

City

hyderābād

Industry

pharmaceuticals

Skill

gmp, regulatory affairs, validation, regulatory submissions, pharmaceutical industry, regulatory requirements, capa, sop, technology transfer, change control, quality system, gxp, quality assurance, analytical chemistry, glp

Experience

regulatory affairs professional, global regulatory affairs

dr. reddy's laboratories

2008-4 - 2013-9 · 5 yrs 6 mos

* Public Company * 10,001+ employees * RDY * Pharmaceuticals industry

quality assurance professional

dr. reddy's laboratories

2001-10 - 2008-4 · 6 yrs 7 mos

* Public Company * 10,001+ employees * RDY * Pharmaceuticals industry

technical trainee, quality assurance

dr. reddy's laboratories

2001-9 - 2001-10 · 2 mos

* Public Company * 10,001+ employees * RDY * Pharmaceuticals industry

hetero labs limited

hetero drugs ltd

2013-9 - Present · 13 yrs 1 mo

* Privately Held * 10,001+ employees * Pharmaceuticals industry

Education

education

1986-1 - 1989-1 · 3 yrs 1 mo

saint mary's school

education

1983-1 - 1986-1 · 3 yrs 1 mo

sikkim manipal university - distance education

commerce

2014-1 - 2016-1 · 2 yrs 1 mo

dr.lankapalli bullayya junior college, visakhapatnam

physics

1994-1 - 1996-1 · 2 yrs 1 mo

Secured First Class. Higher Secondary (Maths, Physics and Chemistry) from Board of Intermediate Education, Governement of Andhra Pradesh, INDIA. Activities and Societies: Best Performer in Chemistry and Linguistics

a.u.m.s.n.p.g.centre, kkd

physics

1996-1 - 1999-1 · 3 yrs 1 mo

Best performer in Chemistry and Linguistics Activities and Societies: Actively participated in Social Initiatives of the Governement, like Janmabhoomi (an initiative of public and student participation scheme by the Government of Andhra Pradesh, INDIA). Activitely participated in blood donation camps. Actively participated in elecutions, debates, and extracirricular activities.

a.u.m.s.n.p.g.centre, kkd

chemistry

1999-1 - 2001-1 · 2 yrs 1 mo

FirstSecured first division in Post graduation studies [M.Sc (Analytical Chemistry)] from Andhra University Campus, Visakhapatnam, Andhra Pradesh, INDIA.