Regulatory Affairs Manager - Biosimilars

The purpose of this position is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.

This position will support:

• Global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plans throughout the product lifecycle.
• Development of CMC and analytical dossiers required for registration of biosimilar products in support of agency interactions, global clinical trials, and initial marketing applications.
• Initial management of long term CMC planning and regulatory CMC submissions for licensed products.

Key Activities:

• Contributes to one or more product development teams; may act as product lead for one or more products.
• Provides CMC regulatory oversight in the development, communication, and implementation of global regulatory strategies
• Executes regulatory strategy with respect to preparation of submissions including analytical similairty packages and quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents.
• Supports cross-functional teams in development and submission of Quality/Operations/CMC regulatory documents, including responses to questions from regulatory authorities
• Supports CMC-related agency interactions
• Represents RA CMC at relevant team meetings
• Complies with Amgen Regulatory CMC processes
• Identifies and supports changes to process and strategy in response to internal Amgen initiatives and changes in external regulatory policy and guidance
• Collaborates with other Regulatory Department functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices)

Basic Qualifications

Doctorate degree

OR

Masters degree and 3 years of regulatory, CMC, manufacturing, testing or process/product development experience

OR

Bachelors degree and 5 years of regulatory, CMC, manufacturing, testing or process/product development experience

OR

Associates degree and 10 years of regulatory, CMC, manufacturing, testing or process/product development experience

OR

High school diploma / GED and 12 years of regulatory, CMC, manufacturing, testing or process/product development experience

Preferred Qualifications

Planning and organizing abilities

Managing multiple activities

Problem solving abilities

Setting priorities

Team work

Multi-disciplinary nature

Dealing with ambiguity

Action oriented

Flexibility with day-to-day requirements

Conflict management

Strong oral and written communication skills

Excellent interpersonal and organizational skills

Ability to provide support for team members

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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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

Equal Opportunity Statement

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 a 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 an accommodation.