Regulatory Affairs Associate Job for B.Sc and M.Sc.
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 Marketing authorization and clinical 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
- 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.
Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.