Amgen

Regulatory Affairs Manager - Biosimilars

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 06, 2020
Ref
R-105523
Required Education
High School or equivalent
Position Type
Full time
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

Development of CMC and analytical dossiers required for registration of biosimilar products

Management of long term CMC planning and regulatory CMC submissions for licensed products

Key Activities:

Regulatory Strategy and Filing

Provide CMC regulatory oversight in the development, communication, and implementation of global regulatory strategies in support of the Regulatory Biosimilars Team

Ensure regulatory documents (including analytical similarity packages and quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents) are developed with high quality and delivered in a timely manner, as directed by the RA CMC Lead

Support cross-functional teams in development and submission of Quality/Operations/CMC regulatory documents, including responses to questions from regulatory authorities

Maintain the CMC sections of product licenses per regulatory requirements, including updates

Support CMC-related agency interactions

Represent RA CMC at relevant team meetings as directed by the RA CMC Lead

Collaborate with other Regulatory Department functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices)

Comply with Amgen Regulatory CMC processes

Regulatory Intelligence

Generate and communicate CMC intelligence to the Amgen biosimilars community as directed by the RA CMC Lead

Collaboration

Support regulatory risk assessments by the Regulatory Biosimilars function and CMC filing teams

Communicate CMC issues, progress, and metrics to the Regulatory Biosimilars Team

Represent the Regulatory Biosimilars Team on internal Amgen CMC committees

Basic Qualifications

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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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