Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Post : Regulatory Affairs Associate
Key responsibilities include:
• To prepare applications to Markeitng authorrization and clincial trial. Support team for preparation of dossier for timely submissions to the regulatory authorities
• Compile clinical trial applications, Import & export license submission, approval and maintenance for clinical trials per local regulations, ensuring timely submissions, follow-up with and approval from the regulatory authorities
• Respond to regulatory queries seeking support and feedback from appropriate functions within Amgen
• Ensure regulatory compliance by managing regulatory submissions for notification and/ or approval during the course of the execution of each clinical study including preparation and submission of annual study status reports and study completion reports
• Ensure timely registration and maintenance of all approved clinical trials in the Indian clinical trials registry (CTRI)
• Ensuring that local labeling requirements are developed in alignment with local regulatory requirements and Amgen standards
• Participate in process improvement initiatives, and recommend process changes where necessary
Candidate Profile
• Education: Bachelor’s degree or Master degree in Life Sciences or equivalent or B Pharm or M Pharm
• 1- 4 years of related professional experience in the pharmaceutical / biotechnology pharmaceutical or medical device industry for India registration
• Strong oral and written communication skills.
• Knowledge of Indian regulations, directives and guidelines preferred.
Additional Information:
Location: Mumbai
Auto req: R-49040
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
End Date: 15th February, 2018
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