Amgen
Amgen, one of the world’s leading biotechnology companies, is hiring freshers and experienced professionals for the role of Associate – Clinical Trial Submission Management at its Hyderabad office. This is a remarkable opportunity for individuals passionate about clinical research, regulatory affairs, and global compliance to join a high-impact team and contribute to life-changing therapies.
🧬 About Amgen
Amgen is a pioneer in biotechnology, dedicated to unlocking the potential of biology for patients suffering from serious illnesses. With a focus on innovation, Amgen develops and delivers advanced therapies by leveraging cutting-edge science and a strong commitment to quality and compliance.
🎯 Role Overview
Associate – Clinical Trial Submission Management
Location: India – Hyderabad
JOB ID: R-206611
WORK LOCATION TYPE: On Site
What you will do
Let’s do this. Let’s change the world. In this vital role you will help ensure technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, local offices, external partners and regulatory authorities.
Roles & Responsibilities:
- Be assigned to one or more Amgen products under development to ensure Clinical Trial Application approvals in the EU throughout the whole study lifecycle. As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with the EU Clinical Trials Regulation (EU CTR) for every Clinical Trial submission dossier through close cross-functional collaboration.
- Support the EU Regulatory Lead to prepare Submission Content Plans and documentation for regulatory deliverables.
- Be responsible for the Quality control (QC) of data and documents before CTIS upload.
- Be responsible for the cross-functional coordination of Requests for Information (RFI) process from initial reviewing and triaging, through to technical document preparation, submission in CTIS and archive in the relevant internal system.
- Be the critical technical coordinator for Clinical Trial Notifications through CTIS, ensuring accurate and timely input of data and archive into the relevant internal system.
- Assist with the definition, development, and implementation of processes to meet evolving CTIS needs.
- Raise, advise and resolve any issues that may impact submission process or timelines within CTIS.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
- Bachelor’s degree and 0 to 3 years of directly related experience OR
- Diploma and 4 to 7 years of directly related experience
Preferred Qualifications:
- Practical experience with Veeva Vault
- Familiarity with global regulatory processes and standards
- Ability to quickly learn new software, regulations and processes
- Proactive, innovative problem solver and well-organized teammate
🌍 Why Join Amgen?
Working at Amgen means being part of a mission-driven organization where your work directly impacts patients worldwide. This role offers an excellent platform for career development in regulatory sciences, clinical operations, and global compliance.
If you’re ready to step into a dynamic environment and make a real difference, this is your chance!
🔗 How to Apply
Visit Amgen Careers and search for Job ID: R-206611 to apply.
OR
To apply for this job please visit careers.amgen.com.
