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Hiring for Assistant Manager Regulatory for Leading Pharma company in

Company:
SHREE BALAJI MANAGEMENT CONSULTANTS (SBMC)
Location:
Chandigarh, Chandigarh, 160017, India
Salary:
20000-30000
Posted:
March 21, 2017
Description:

Dear All,

We are hiring for Assistant Manager Regulatory for Leading Pharma company in Baddi

Designation: Assistant Manager Regulatory Department

Qualification: B-Pharma/M-Pharma

Experience:- Min 3 yr

Responsibilities :

• Experience in resolving the queries as requested by Customers and Regulatory Agencies.

• Experience in handling deficiencies arising from MOH and regulatory authorities.

• Critical review & Compilation of technical documents, TDP (technical document package).

• Wide knowledge and experience for review of manufacturing process validation & analytical method validation SOP's, stability protocols, specification, STPs, Master formula records (MFR's),PDR, check list for TTD's for necessary correction and implementation.

• Preparation of registration documents in various countries along with TSE/BSE,cGMP, etc and other certifications as per Regulatory requirements

• Timely follow up of technical queries of Drug Regulatory Authorities.

• Maintenance of Dossiers and Regulatory documents.

• Coordination with production, QC,CRD & R & D Dept. for regulatory requirements and controls.

• Coordination of customer audits & their Compliances.

• Vendor performance, qualification, & audit for API & Intermediates.

• Co-ordination with manufacturing sites and ensure compliance.

.

Interested candidates can share details to Ms.Ruby at b0kqsp@job2r.com or can drop a call at 9569926032

www.sbmc.co.in