Regulatory Affairs Associate at PAREXEL

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 : Regulatory Affairs Associate

Job Description:
• 1-2 Years CTA preparation and Compilation. Experienced with preparation/review of Clinical Trial Authorization Packages for 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 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

Candidate Profile
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline

Additional Information
Experience: 1-2 years
Qualification: B.Sc, B.Pharm
Location: Bengaluru, Karnataka
Functional Area: Regulatory Affairs
Industry Type: Pharma
Job ID : 44545BR
End Date: 25th July, 2018