Career Category

Job Description

Job Summary

Perform a variety of administrative activities to support team members within local Regulatory Affairs / Safety. This position is on a contract worker type.

Key Activities

Technical support to regulatory/safety for different projects, incl. CTA preparation, regulatory projects, safety related tasks, translations. Perform physical submission packages to BDA, EC, receive, deliver and disseminate authorities’ correspondence/approvals. Validate fees with health authorities’ account departments.  

Maintenance of regulatory registers; perform archiving activities.

Prepare and process routine forms, documents and correspondence.
Answer phones, making proper referral or handling as appropriate
Disseminates information to appropriate parties in a timely manner; monitors and/or follows-up on appropriate items
As appropriate, open, read, sort, prioritize and distribute incoming mail; ensure outgoing mail and packages are prepared properly and scheduled for delivery
Plan and organize work to ensure accurate and logical organization of files, documents and records; ensure effective control of forms; control confidentiality of files as necessary
Copy/scan documents.
Monitor office supply inventory and order as necessary in coordination with receptionist.
Manage multiple and/or complex calendars
Coordinate domestic/international travel arrangements within local Regulatory Affairs department
Utilize basic forms (i.e. check request, expense reports)
Coordinate onsite/offsite meetings under minimal supervision ( within Regulatory Affairs/Safety function)
Interact with outside vendors
Type presentations
Organize and expedite workflow to comply with deadlines and priorities
Prepare and process forms, documents and correspondence; anticipates, revises and sends correspondence (liaise with receptionist for courier services)
Compile data and information to be sent to various external groups
May take basic meeting minutes/action items; needs to ask others to review or clarify terms
Project tracking: (i.e. budget, database, timelines)
Serve as a point of contact for information regarding areas of responsibility
Interact effectively with various levels of management
Coordination of local Regulatory Affairs/Safety function related activities with other ACs.
Assist with special projects as requested by manager

Knowledge and Skills

Excellent phone etiquette
Excellent written and verbal communication skills

Excellent written and spoken English
Strong organizational and interpersonal skills
Able to manage multiple tasks, prioritize and meet deadlines
Able to resolve problems with limited supervision
Knowledge of relevant corporate and government laws and regulations impacting job function
Microsoft Suite: Word, Excel, Powerpoint, Outlook

Education & Experience (Basic)

Bachelor’s degree or 2 years of directly related experience

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.