Career Category

Operations

Job Description

As an Associate, Regulatory Data Management you will help ensure the compliance of our regulatory data via the smooth compliant flow of information across our systems and processes.

Roles & Responsibilities:

• Provide support on maintaining our Regulatory Information Management (RIM) system.
• Create and archive clinical trial, marketing application submissions and health Authority correspondence within the organisation RIM system.
• Serve as a point of contact between regulatory representatives, CMC, safety, partners and the submission management team.
• Provide support on creating, running and analysing reports for data streamline projects.
• Provide support within data management global team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods.
• Adhere to Amgen processes, policies, guidelines, SOPs and training documentations.

Required Knowledge and Skills:

• Highly motivated, organised, and detailed oriented team player.
• Familiarity with regulatory procedures and filings.
• Familiarity with global clinical and regulatory health authorities’ requirements e.g. FDA, EMA, MHRA etc.
   

Preferred Knowledge and Skills:

• Working knowledge of the Veeva Vault platform is preferred

Basic Education and Experience:

• Master’s degree and some directly related experience

OR

• Bachelor’s degree and 2 years of directly related experience

OR

• Associate’s degree and 4 years of directly related experience

OR

• High school diploma / GED and 5+ years of directly related experience

Preferred Education and Experience:

• Practical experience with regulatory data standards, such as IDMP

.