Job Description
• 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
• 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
• 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
Experience : 1-4 years
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma
Functional Area : Regulatory
Job ID: R-49040
End Date : 15th February, 2019
Experience : 1-4 years
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma
Functional Area : Regulatory
Job ID: R-49040
End Date : 15th February, 2019
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