Are you passionate about making a difference in the pharmaceutical industry? Do you want to be part of a team that is changing the world? Amgen, a leading biotechnology company, is seeking an Associate GRAAS Global Regulatory Affairs and Safety Operations professional to join their team in Hyderabad, India. This exciting opportunity will allow you to play a vital role in ensuring technical compliance of clinical trial submissions and contributing to the company’s mission to serve patients.
Job Overview
As an Associate GRAAS Operations, you will be responsible for ensuring the smooth and compliant flow of information between all functional areas, local offices, external partners, and regulatory authorities. You will be assigned to one or more Amgen products under development, ensuring Clinical Trial Application approvals in the EU throughout the whole study lifecycle. Your expertise in the EMA Clinical Trial Information System (CTIS) will be crucial in ensuring compliance with the EU Clinical Trials Regulation (EU CTR) for every Clinical Trial submission dossier.
Key Responsibilities
- Ensure compliance with EU Clinical Trials Regulation (EU CTR) for every Clinical Trial submission dossier
- Support the EU Regulatory Lead in preparing Submission Content Plans and documentation for regulatory deliverables
- Perform Quality Control (QC) of data and documents before CTIS upload
- Coordinate cross-functional Requests for Information (RFI) process
- Act as a technical coordinator for Clinical Trial Notifications through CTIS
- Assist in defining, developing, and implementing processes to meet evolving CTIS needs
- Raise, advise, and resolve any issues that may impact submission process or timelines within CTIS
Requirements
To be considered for this role, you should have:
- Bachelor’s degree and 0-3 years of directly related experience OR
- Diploma and 4-7 years of directly related experience
- Practical experience with Veeva Vault (preferred)
- Familiarity with global regulatory processes and standards (preferred)
- Ability to quickly learn new software, regulations, and processes
- Proactive, innovative problem solver and well-organized teammate
What Amgen Offers
At Amgen, you can expect a competitive benefits package, a collaborative culture, and opportunities for professional and personal growth and well-being. In addition to the base salary, Amgen offers comprehensive Total Rewards Plans that are aligned with local industry standards.
