Regulatory Affairs Manager CMC

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Regulatory Affairs Senior Manager Regional Regulatory Lead

Live

What you will do

Lets do this. Lets change the world.The Regulatory Affairs Manager CMC Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; re

ports issues to RA CMC product team management.

Key Responsibilities Include:

• Generate and execute of global and country-specific regulatory strategies

• Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments

• Develop global dossiers for CMC content for initial submissions, variations and amendments

• Support change management activities

• Develop response strategy and respond to health authority questions

• Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans

• Liaise with local regulatory teams to align on filing strategy

• Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system

• Follow established department regulatory processes to ensure cross-product alignment

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications

Doctorate degree
OR
Masters degree and 3 years of directly related experience
OR
Bachelors degree and 5 years of directly related experience
OR
Associates degree and10 years of directly related experience
OR
High school diploma / GED and12 years of directly related experience

Preferred Qualifications

Experience in manufacture, testing (QC/QA or clinical), or distribution

Regulatory CMC experience

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
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.