Senior Associate - Regulatory Affairs (US-REMOTE)

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Regulatory Affairs (Open to remote)

Live

What you will do

Let’s do this. Let’s change the world. In this key role you will, under the direction of a Regional Regulatory Lead, assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Key responsibilities include:

• Assist US Regulatory Lead to support US regulatory activities (e.g. IND development and submission, meeting preparations)

• Provide and maintain IND/BLA documentation support (e.g. annual reports, amendments) in collaboration with US Regulatory Lead (and Regional Reg Leads, as appropriate)

• Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications

• Review US component of the Global Regulatory Strategy Plan and provide input to operational deliverables

• Ensure compliance with submissions to regulatory agencies

• Coordinate collection of functional documents in support of regulatory applications

• As appropriate facilitate and participate in GRT to support the implementation of regulatory strategy

• Coordinate QC of regulatory documentation (e.g. briefing packages)

• Provide primary authorship to routine regulatory correspondence, if needed (cover letters, etc.)

• Prepare regulatory packages and cross-reference letters to support investigator initiated studies

• Assist USRL and GRL, as needed

• Complete regulatory forms to support agency communications

• Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions, as needed

• Support process improvement initiatives, standards development, and metrics

• Assist in template development and maintenance, as needed

• Respond to specific requests from and communicate relevant issues to GRT

• Assist in development of Regulatory Position with teams

• Actively support regulatory compliance

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The highly competent professional we seek is a go-getter with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree & 2 years of Regulatory experience OR

Associates degree & 6 years of Regulatory experience OR

High school diploma / GED & 8 years of Regulatory experience

Preferred Qualifications:

• Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum

• Regulated industry, science or clinical practice experience

• Timeline management

• Strong communication skills- oral and written

• Organizational skills

• Ad hoc meeting support

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Fl