Executive / Sr. Executive – Regulatory Affairs (API) CTX LIFESCIENCES PVT. LTD. ~ PHARMANAUKRI.IN

Tuesday, May 11, 2010

Executive / Sr. Executive – Regulatory Affairs (API) CTX LIFESCIENCES PVT. LTD.

7:38 AM Leo Group India No comments

To prepare and file dossier for USDMF/ CEP/EDMF/ DMF-Health Canada and any other countries as the requirement may be.

Summary

Experience:

3 - 5 Years

Location:

Surat

Compensation:

No bar for right candidate

Education:

UG - B.Pharma - Pharmacy,B.Sc - ChemistryPG - M.Pharma - Pharmacy,M.Sc - Chemistry

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Regulatory Affairs Mgr

Functional Area:

Healthcare, Medical, R&D

Posted Date:

10 May

Desired Candidate Profile

Bsc /Msc / B Pharm /M Pharm/D.pharm, - with hardcore experience in Regulatory Affairs (API.)

Job Description

- To prepare and file dossier for USDMF/ CEP/EDMF/ DMF-Health Canada and any other countries as the requirement may be.

- To file amendments, revision/ notification to regulatory agencies and customer.

- Preparation and submission of open part

- Response to Customer query against submission.

- Co-ordination with various functionaries to get the documents and review of the documents.

Keywords: Regulatory Affairs, QA & RA, Surat, M. Pharma, B. Pharma. M.Sc, Graduate,

Company Profile

We, CTX Life Sciences Pvt. Ltd were started in 2006 and is headquartered at Surat, Gujarat, India. We manufacture Active Pharmaceutical Ingredients (APIs), & Intermediates. CTXLS has created a strong product portfolio, building on its R & D Expertise, regulatory capabilities and multi scale production capacities. CTXLS has been established with a vision to become a major global player and as part of our vision we are already into regulated market & our facility is approved by USFDA in April -2010

For a person seeking challenging career opportunity, the company offers an invigorating environment conducive to high levels of performance, besides a competitive remuneration package.