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Regulatory Affairs - Clinical Trials Jobs in Max

By: Pharma Jobs | Views: 1802 | Date: 18-Dec-2013

Max Neeman Medical InternationalMax Neeman International is India"s leading contract research organization providing full range of clinical development services to small, mid-size and global pharmaceutical, biotech and medical device companies. The portfolio of the services include comprehensive Phase I-III clinical trials, regulatory submissions, phase IV post approval programs & commercialization services.

Assistant Manager - Regulatory Affairs (clinical Trials)

by Max Neeman Medical International in Delhi


Max Neeman Medical International

Job Description

POSITION RESPONSIBILITIES

The Assistant Manager - Regulatory Affairs will perform the following activities:

*Review the protocol/study outline thoroughly
 *Review the clinical data available from the previous studies from the Investigators Brochure (IB)
*Review the stability and manufacturing data available in the Investigational Medicinal Product Dossier
*Review the checklist of the documents required for the submission.
*Review all the documents sent by the client as per the checklist sent to the sponsor.
*Prepare and Review of the complete regulatory dossier for submission.
*Make Regular visits to the regulatory offices to get an update of the approval status and follow-up of the application.
*Escalate any query generated by the regulatory office to the In charge (Regulatory)
*Receive the query generated by the regulatory office and send the scanned copy to the Incharge.
*Review the reply sent by the sponsor in the regulatory office.
*Review the Approval letter for correctness
Salary:

Not Disclosed by Recruiter

Industry:

Pharma / Biotech / Clinical Research

Functional Area:

Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:

Drug Regulatory Affairs/Documentation

Role:

Regulatory Affairs Manager

Keyskills:

Excellent Communication SkillsExperince in Regulatory Affairs - Clinical Trials

Desired Candidate Profile

Education:

UG - B.Pharma - Pharmacy, B.Sc - Any Specialization, Biology
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required

Please refer to the Job description above

Company Profile

Max Neeman Medical International
http://www.neeman-medical.com/
Max Neeman International is India"s leading contract research organization providing full range of clinical development services to small, mid-size and global pharmaceutical, biotech and medical device companies. The portfolio of the services include comprehensive Phase I-III clinical trials, regulatory submissions, phase IV post approval programs & commercialization services.

Contact Details
Recruiter Name:

Neha Sameen

Address:

Max House 01, Dr. Jha Marg, Okhla-III NEW DELHI,Delhi,India

Email Address:

Telephone:

011-40772100


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