Dear All now get GMP News, FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters.. GMPVIOLATIONS

Tuesday, May 22, 2012

Executive/Senior Executive-Regulatory Affairs by Clinigene International Limited in Bengaluru/Bangalore


Job Description
Job Responsibility:

•Development of departmental SOPs and training of RA personnel and stake holders on same.

•Impart training to the RA personnel / stake holders on SOPs, regulations, functions of RA department after being designated by Head-RA.

•Preparation, review and amendments of required regulatory documents and / information for submission to regulatory authorities for Phase I-IV clinical trials and Bioavailability and Bioequivalence studies as per departmental SOPs.

•Coordinating with the interfacing departments for procuring appropriate information for submission to regulatory authorities and registering clinical trials with CTRI, obtaining application fee for conducting clinical trials and BA/BE studies from the concerned departments and /Sponsor wherever applicable. 


•Notification of Serious Adverse Events to the regulatory authorities.

•Archival of approvals, licenses, study dossiers appropriately in the regulatory affairs department.

•Submission of subsequent protocol amendments, clinical trial reports, annual status reports and any study related information to the regulatory authorities.

•Maintaining and updating Clinigene Site Master File.

•Registration of clinical trials with Clinical Trial Registry- India (CTRI) wherever applicable.

•Coordinating with the shipping service provider for handover and retrieval of the original licenses.

•Carry out any other activity that may be assigned from time to time by the Head-RA
Key Responsibilities:

•Review and preparation of regulatory applications, complying with latest guidelines, tracking applications and preparing communications to regulatory agency
Salary:
Best in the industry
Industry:
Pharma, Biotechnology, Clinical Research
Functional Area:
Healthcare, Medical, R&D
Role Category:
Drug Regulatory Affairs/ Documentation
Role:
Drug Regulatory Director
Keyskills:
Regulatory associate, CTRI
Desired Candidate Profile
Education:
(UG - Any Graduate - Any Specialization, Graduation Not Required) AND (PG - M.Pharma - Pharmacy)
Please refer to the Job description above
Company Profile
Clinigene International Limited
http://www.clinigeneintl.com/
Clinigene International Limited is a full-service Clinical Research Organization that partners global pharma and biotech companies in their clinical development programs. Clinigene's services span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs. We have extensive working knowledge of a wide range of products such as biologics, biotechnology products, vaccines, devices and small molecules. All activities are carried out in strict compliance with regulatory and ICH GCP requirements.

Specialties
Phase I-IV clinical Trials, BA/BE & PK/PD studies, Diabetology, Oncology, Rheumatology, Infectious diseases, Gastroenterology, Nephrology, Cardiology, Neuropsychiatry, Immunology

Contact Details
Executive Name:
Alphonsa Varghese
Telephone:
08028082813



If above Post not related to you please forward to your friends..because its CAREER Matter. Refer www.pharmanaukri.info

0 comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...
Enter your email address: Updated Regularly || Click here for Get Free SMS Alerts |

nmr

 Jobs By Category

Manufacturing/Production     Quality Control    Quality Assurance

Regulatory Affairs     Research & Development     Clinical Research

Warehouse/Stores HR Jobs     Contract Manufacturing     Supply Chain / PPIC

Purchase jobs      Marketing PharmacoVigilance 

 Jobs By Location

Baddi     Bhopal     Chandigarh     Solapur     Hosur     Gangtok     Gurgaon    

Mohali     Baroda Ankleshwar     Ahmedabad     Delhi      Mumbai      Chennai    

Hyderabad     Bangalore     Goa     Gujarat      Pune    

 Jobs By Qualification  

Ph.D     M.Sc     MBBS     M.Pharmacy     MBA     M.Com      M.Tech     B.Tech     

B.Pharmacy      B.Sc     D.Pharmacy     B.Com     Intermediate   Any Graduate      

ITI     SSC    

Jobs for Freshers

Freshers

Recent Posts

Enter Key word then search

Share

Twitter Delicious Facebook Digg Stumbleupon Favorites