PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Associate Regulatory Affairs
Job Description
• Experienced with preparation/review of Clinical Trial Authorisation Packages for Asian countries including India.
• Awareness of regulatory requirements
• Responsible for the coordination and the preparation of /packages for MAA.
• Review and evaluate technical and scientific data and reports required for submission
• Monitor applicable regulatory requirements; assure compliance with the company’s and external standards Co-ordinate with global team for documentation
• Responding to queries raised by regulatory authorities
• Maintain regulatory files in a format consistent with requirements
• Label reviews
• Tracking submissions
• CTRI registration
Qualifications:
1-2 years experience in regulatory affairs with preparation of CTAs for Asian countries
Additional Information:
Experience: 1-2 years
Location: Gurgaon- Haryana
Functional Area: DRA
Requisition: pare-10038194
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 5th January, 2015
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