Associate Regulatory Affiars
1 - 2 Years
Delhi
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 registrationCompany Profile
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 registrationCompany Profile
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract research, consulting, medical communications, and technology solutions and 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. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices nearly 80 locations in over 50 countries around the world, and has approximately 18,000 employees.
In India, PAREXEL has seven offices spread across five cities: Bengaluru, Hyderabad, Chandigarh, New Delhi and Mumbai. These offices are home to more than 3,000 employees.
Our two new offices in Bengaluru, called IndiQube and EcoWorld, were strategically designed to support a variety of work styles. There are collaboration zones in bright colors, freestanding high tables with stools to serve as informal meeting spaces, quiet rooms for group meetings, and private booths for phone calls. This innovative workspace encourages teamwork, and allows for sufficient flexibility to utilize the office beyond workstations.
In India, PAREXEL has seven offices spread across five cities: Bengaluru, Hyderabad, Chandigarh, New Delhi and Mumbai. These offices are home to more than 3,000 employees.
Our two new offices in Bengaluru, called IndiQube and EcoWorld, were strategically designed to support a variety of work styles. There are collaboration zones in bright colors, freestanding high tables with stools to serve as informal meeting spaces, quiet rooms for group meetings, and private booths for phone calls. This innovative workspace encourages teamwork, and allows for sufficient flexibility to utilize the office beyond workstations.
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