Associate Regulatory Affairs
1 - 2 YearsDelhi
Job Description
Experienced with preparation/review of Clinical Trial Application Packages for Asian countries including India.
Awareness of regulatory requirements
Review and evaluate technical and scientific data and reports required for submission
Monitor applicable regulatory requirements; assure compliance with the companys 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
Awareness of regulatory requirements
Review and evaluate technical and scientific data and reports required for submission
Monitor applicable regulatory requirements; assure compliance with the companys 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
Company Profile
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You'll be surrounded by supportive leadership and a brilliant team who share a common goal - to improve the lives of millions of patients.
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