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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
Best in the industry
Pharma, Biotechnology, Clinical Research
Functional Area:
Healthcare, Medical, R&D
Role Category:
Drug Regulatory Affairs/ Documentation
Drug Regulatory Director
Regulatory associate, CTRI
Desired Candidate Profile
(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
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.

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

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