Macleods Pharmaceuticals Ltd. Invites Officer/ Sr. officer - Regulatory affairs US- ANDA

Macleods Pharmaceuticals is a dream come true for a medical doctor, Dr.R.Agarwal, the Managing Director, who had a vision to provide quality health care to humanity. Dr. R. Agarwal incorporated Macleods in 1986 with a mission to spread the wings of health globally.
Macleods has a dedicated team of over 5500 personnel who diligently contribute towards the10 billion (US$ 220 million) turnover of the organization.
Today Macleods is a company with world class manufacturing, strong R&D and is amongst the leading pharmaceutical companies in India.

Post: Officer/ Sr. officer - Regulatory affairs US- ANDA

Job Description:
- Comiplation of US - ANDA dossiers
- Responses to queries raised by USFDA
- Review of various technical documents used in pre- registration and post- registration activities
- Knowledge of drug product life cycle
- Co-ordiantion with various departments for collection of various technical documents as required for registration.
- Knowldge of guidelines for ICH and USFDA

Additional Information:
Experience: 1-3 Years
Location: Mumbai
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 5th March, 2012