Friday, June 15, 2012
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Executive - Regulatory Affairs
Bliss Gvs Pharma Limited was incorporated on 11th December, 1984 as Public Limited Company. It is listed on Bombay and National Stock Exchange. The Manufacturing Plant is located at Palghar (approximately 90 kms from Bombay) in an industrial area which is well developed with all infra-structural facilities. The plant is 1.5 kms. From Palghar Railway Station on the Western Railway. The company's most unique product is 'Today' Vaginal Contraceptive, a safe female contraceptive aimed at furthering planned parenthood and is also an established method for preventing conception
Executive - Regulatory Affairs
Job Location: Mumbai (Bombay)
Job Description: - Prepare and Review Registration Dossiers for registration for submission across various health authorities like UK-MHRA
- Ensuring On time submissions of Registration Dossiers & Renewal of Marketing Authorizations & Approvals
- Act as the Single Point of Contact between the Business Development/Marketing team and the Regulatory Affairs Department
- Ensure high level of employee engagement for the RA team members at all times
- Assist Senior Management in Devising the Strategy for Regulatory Affairs & Compliance
- Responsible for implementing training plans for ensuring RA knowledge dissemination within the RA team as well as other departments like QA/QC
- Liaison with external agencies/service provides for reviewing quality of services provided like BA/BE studies,Clinical Trial
- Ensuring On time submissions of Registration Dossiers & Renewal of Marketing Authorizations & Approvals
- Act as the Single Point of Contact between the Business Development/Marketing team and the Regulatory Affairs Department
- Ensure high level of employee engagement for the RA team members at all times
- Assist Senior Management in Devising the Strategy for Regulatory Affairs & Compliance
- Responsible for implementing training plans for ensuring RA knowledge dissemination within the RA team as well as other departments like QA/QC
- Liaison with external agencies/service provides for reviewing quality of services provided like BA/BE studies,Clinical Trial
Functional Area: Pharmaceuticals
Functional Role: Drug Regulatory Officer
Thorough Knowledge of Good Manufacturing Practices across dosage forms like Solid, Semi-Solid & Sterile
Prior Experience in Regulatory Affairs focussing on Regulated Markets like EU
Exposure to communication/coordination with various agencies like UK-MHRA, MCC, TGA, ANVISA etc.
Proven Track Record of Managing the Product Registration/Marketing Authorization Lifecycle from Preparing Registration Dossiers, Answering Technical Queries to Pharmacovigilance Process
Should have exposure to GMP Audits from Various agencies like EU-GMP. UK-MHRA or ANVISA.
Prior Experience in Regulatory Affairs focussing on Regulated Markets like EU
Exposure to communication/coordination with various agencies like UK-MHRA, MCC, TGA, ANVISA etc.
Proven Track Record of Managing the Product Registration/Marketing Authorization Lifecycle from Preparing Registration Dossiers, Answering Technical Queries to Pharmacovigilance Process
Should have exposure to GMP Audits from Various agencies like EU-GMP. UK-MHRA or ANVISA.
Candidate Requirement
B.Pharm/
Excellent Communication, Reasoning & Interpersonal Skills.
Ability to handle multiple projects/ deliverables at the same time.
Go Getter & Highly Motivated
Excellent People handling Skills
Thorough Knowledge of cGMP
Well versed with MS-Office.
Excellent Communication, Reasoning & Interpersonal Skills.
Ability to handle multiple projects/ deliverables at the same time.
Go Getter & Highly Motivated
Excellent People handling Skills
Thorough Knowledge of cGMP
Well versed with MS-Office.
Experience: 0 - 2 years
Qualification: B.PHARMA(Pharmaceutics), B.Pharma (Hons)(Pharmacy)
Preferred Resume Format: MS-Word
Compensation Details
Salary: 1.50 Lakh to 3.00 Lakh (Indian Rupees) per annum
Devansh Khanna
102 Hyde Park, Saki Vihar Road,
Andheri (E)
Mumbai (Bombay), Maharashtra
India 400072
Phone: 02242160000
Website: http://www.blissgvs.com
Posted in: Pharma Jobs
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