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Sr.Exe - Regulatory Affairs (Formulations),Chennai

4 - 6 yrs
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Not Disclosed by Recruiter Openings: 1 Posted 30+ days ago Job Applicants: Less than 10 Job Views: 647

Job Description

 
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    Job Description

    Review submission of approvable ANDAs / Registration of dossiers related to Orchid Healthcares (OHC) products across the globe, as per respective regulatory requirements of different countries.
    Review and submission of responses to the queries from Regulatory Agencies.
    Co- ordination with external Regulatory Agencies for regulatory submissions and approvals.
    To prepare the schedule for Dossier submission and monthly report submission.
    To train personnels on the awareness of International Regulatory guidelines ( on line Training). Building good team and motivating them in all direction. Training team to prepare documents for National market Lic. Submission for manufacturing licenses, test licenses, CPP, cGMP certificates from Indian Drug control administration
    Co- ordination with inter and intra department to make available of the documents.
    Preparation of budget for the departmental expenses and monitoring the same.
    Regulatory feedback updation on latest regulatory information to other departments. Providing regulatory support to other department
    Preparation checklists and SOP's for regulatory department activities. Tracking of dossiers submission till the Launch.

Salary: Not Disclosed by Recruiter

Industry: Construction, Engineering, Cement, Metals

Functional Area: Engineering Design , R&D

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type: Full Time, Permanent

Keyskills

Education-

UG: Any Graduate - Any Specialization

PG:Any Postgraduate - Any Specialization

Company Profile:

Naman Staffing

Naman Staffing is a dedicated business unit of Naman Group - one of the fastest growing Human Resource consultants of Indian origin serving in India, South Asia and UAE. With offices in Mumbai and Vadodara and representative base in Ahmedbad, Pune & Hyderabad, we are well positioned to serve our client across geographies and locations.
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