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:
Doctorate degree
OR
Master’s degree and 3 years of regulatory, CMC, manufacturing, testing or process/product development experience
OR
Bachelor’s degree and 5 years of regulatory, CMC, manufacturing, testing or process/product development experience
OR
Associate’s 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.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
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.
- 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)
Doctorate degree
OR
Master’s degree and 3 years of regulatory, CMC, manufacturing, testing or process/product development experience
OR
Bachelor’s degree and 5 years of regulatory, CMC, manufacturing, testing or process/product development experience
OR
Associate’s 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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
-
Seniority level
Not Applicable -
Employment type
Full-time -
Job function
Science, Writing/Editing, and Other -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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