1+ months

Sr. Manager - Regulatory Affairs CMC

Amgen
Cambridge, MA 02138
  • Job Code
    118753455
Amgen

Job ID: R-95096
Location: Cambridge, MA, US 02139

Amgen is seeking a Regulatory Affairs Sr. Manager (CMC) to join our team and work from Amgen's beautiful Cambridge, Mass, campus. To learn more about this position and Amgen:

The Global CMC Device & Biosimilar Regulatory Affairs, and Business Operations role is to facilitate product development and global registration for marketed products by developing and executing regulatory strategies and effective regulatory agency interactions.

The Regulatory Affairs CMC Lifecycle team is responsible for execution and/ or coordination of all global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of regulatory strategy. Amgen is seeking a Sr. Manager to provide oversite to a team of global product leads located primarily on the East Coast of the United States. The Sr. Manager will have oversite of a portfolio of commercial products. They will also be responsible for staff management and develop.

Key Activities:

Manages a team responsible for post-approval variations for marketed products; may act as product lead for one or more products as needed. Provides strategic regulatory input and regulatory risk assessments for product teams. Executes regulatory strategy with respect to preparation of submissions; 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; reports issues, progress and metrics to RA CMC product team management.

Knowledge and Skills:

Specialized knowledge in post-approval CMC changes. Knowledge of biosimilars and gene therapy products.

Basic Qualifications:

Doctorate degree and 2 years of Regulatory CMC experience

OR

Master's degree and 6 years of Regulatory CMC experience

OR

Bachelor's degree and 8 years of Regulatory CMC experience

OR

Associate's degree and 10 years of Regulatory CMC experience

OR

High school diploma / GED and 12 years of Regulatory CMC experience

Preferred Qualifications:

Experience in post-approval Regulatory CMC experience.

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.

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

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.

PI118753455

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95096<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is seeking a <b>Regulatory Affairs Sr. Manager (CMC)</b> to join our team and work from Amgen's beautiful Cambridge, Mass, campus. To learn more about this position and Amgen: <br><br>The Global CMC Device & Biosimilar Regulatory Affairs, and Business Operations role is to facilitate product development and global registration for marketed products by developing and executing regulatory strategies and effective regulatory agency interactions.<br><br>The Regulatory Affairs CMC Lifecycle team is responsible for execution and/ or coordination of all global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of regulatory strategy. Amgen is seeking a Sr. Manager to provide oversite to a team of global product leads located primarily on the East Coast of the United States. The Sr. Manager will have oversite of a portfolio of commercial products. They will also be responsible for staff management and develop.<br><br><b>Key Activities: </b><br><br>Manages a team responsible for post-approval variations for marketed products; may act as product lead for one or more products as needed. Provides strategic regulatory input and regulatory risk assessments for product teams. Executes regulatory strategy with respect to preparation of submissions; 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; reports issues, progress and metrics to RA CMC product team management.<br><br><b>Knowledge and Skills:</b><br><br>Specialized knowledge in post-approval CMC changes. Knowledge of biosimilars and gene therapy products.<br><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 2 years of Regulatory CMC experience<br><br>OR<br><br>Master's degree and 6 years of Regulatory CMC experience<br><br>OR<br><br>Bachelor's degree and 8 years of Regulatory CMC experience<br><br>OR<br><br>Associate's degree and 10 years of Regulatory CMC experience<br><br>OR<br><br>High school diploma / GED and 12 years of Regulatory CMC experience<br><br><b>Preferred Qualifications:</b><br><br>Experience in post-approval Regulatory CMC experience.<br><br><b>Amgen </b>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.<br><br><b>Amgen</b> 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.<br><br><b> Amgen </b> provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. <br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/p7z7AAUDQwkjU2o5fdJ64"> <p>PI118753455</p>

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Posted: 2020-03-05 Expires: 2020-04-05

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Sr. Manager - Regulatory Affairs CMC

Amgen
Cambridge, MA 02138

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