Career Category

Job Description

This is an opportunity within the Global Regulatory Affairs and Safety (GRAAS) Department located in Amgen Pvt. Ltd, in Mumbai, India. This role reports to Head of Regulatory Affairs located in Mumbai, India. 

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 

Basic Qualification:

• 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.