officer/ Sr. Officer/ Executive - Regulatory Affairs (APIs) ~ PHARMANAUKRI.IN

Friday, May 13, 2011

officer/ Sr. Officer/ Executive - Regulatory Affairs (APIs)

10:47 PM Leo Group India No comments

Summary

Experience:

1 - 4 Years

Location:

Mumbai

Compensation:

Salary will not be a constraint for the right candidate

Education:

UG - B.Sc - Any Specialization, ChemistryPG - M.Sc - Any Specialization

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Drug Regulatory Dr.

Functional Area:

Healthcare, Medical, R&D

Posted Date:

12 May

Desired Candidate Profile

should have excellent written and spoken communication (English)
should be B.Sc/ M.Sc (Chemistry)

Job Description

Preparation of DMF, Certificate of suitability (CEP) dossiers, technical packages amendments of DMFs/ dossiers
Preparation of annual reports, knowledge of ICH guidelines/ GMP
customer support document preparation
answering queries of Authorities/ Customers
Awareness of the requirements of submissions in US, Europe, Canada, Japan and other countries

Keywords: Regulatory Affairs API, US/ EU DMFs, Bulk drugs

Company Profile

We are a fast expanding pharmaceutical company, with a significant presence in Pharmaceutical Industry since six decades. With a turnover exceeding INR 650 Crores, Our business spans over 40 countries ranging from Asia to Europe. We possess a range of DMFs for our API’s, requisite registrations and dossiers exceeding 300. Our six manufacturing facilities in India have been accredited from global drug Regulatory Authorities including the FDA (USA), MHRA (UK) and MCC (South Africa). To Augment our dynamic plans, we need talented professionals with a proven track recode and commitment.