16 days old

Regulatory Affairs Manager, CMC

Amgen
Thousand Oaks, CA 91360
  • Job Code
    119187578
Amgen

Job ID: R-96065
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Puerto Rico - Juncos, US - Rhode Island - West Greenwich, US - Massachusetts - Cambridge

Amgen is seeking a Regulatory Affairs Manager, CMC to join our team and work from Amgen's beautiful Thousand Oaks, Ca campus. To learn more:

Amgen is searching for a Regulatory Affairs Manager, CMC (Chemistry, Manufacturing and Controls). It is anticipated this person will work from the main corporate campus in Thousand Oaks, CA, however qualified candidates from the AMA (Boston, Massachusetts),ARI (West Greenwich, Rhode Island) and AML (Juncos, Puerto Rico) sites will also be considered.

The Regulatory Affairs Manager, CMC will support the initial registration of an Amgen's KRAS product and will bethe lead for lifecycle management (LCM, Commercial) products, including determining regulatory reporting, and global filing requirements for post-approval variations related to synthetics (small molecule) products. The Manager will also facilitate communication of requirements and strategy to Process Delivery Team (PDT) in addition to the functional areas. The Manager will follow standard department and global marketing template processes to drive consistency across post approval programs.

Serve as Regulatory CMC voice for product teams by providing the following services:
  • Define minimum regulatory filing requirements for post approval programs
  • Provide regulatory strategy through development of marketing application strategic plan and/or events
  • Global regulatory strategy
  • Development of post approval variations including maintenance of applications
  • Maintain product compliance through appropriate regulatory filings and activities
  • Support Change Management activities
  • Manageregulatory agency questions, commitments and periodic reports
  • Facilitate agency interactions, including meeting preparation, meetings and briefing documents
  • Ensure alignment with variation master plans, develop global implementation requirements, and implement changes throughout product life-cycles
  • Liaise with regional regulatory CMC counterparts and other functions within development, operations, and commercial to ensure alignment of globalregulatory strategies, timing, execution and plans
  • Contribute to the Product Delivery Teams Variation Master Plan
  • Maintain information for Center dashboards; and collaborate with other Centers to ensure information alignment
  • Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current
  • Participate as an active member of cross-functional teams including GRT, PDT, PQT, etc., as needed


Basic Qualifications
Doctorate Degree
OR
Master's Degree and 3 years of Regulatory CMC or related technical experience
OR
Bachelor's Degree and 5 years of Regulatory CMC or related technical experience
OR
Associates degree and 10 years of Regulatory CMC or related technical experience

OR

OR
High school diploma / GED and 12 years of Regulatory CMC or related technical experience

Preferred Qualifications
  • Degree in Life Science
  • Experience in Manufacture, Quality, Process Development or other related Pharmaceutical/Biotech industry
  • Regulatory CMC experience with small molecule and Biologic products
  • CMC-specific regulatory knowledge & 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.

PI119187578

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96065<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Puerto Rico - Juncos, US - Rhode Island - West Greenwich, US - Massachusetts - Cambridge<br/><br/>Amgen is seeking a Regulatory Affairs Manager, CMC to join our team and work from Amgen's beautiful Thousand Oaks, Ca campus. To learn more: <br><br>Amgen is searching for a Regulatory Affairs Manager, CMC (Chemistry, Manufacturing and Controls). It is anticipated this person will work from the main corporate campus in Thousand Oaks, CA, however qualified candidates from the AMA (Boston, Massachusetts),ARI (West Greenwich, Rhode Island) and AML (Juncos, Puerto Rico) sites will also be considered.<br><br>The Regulatory Affairs Manager, CMC will support the initial registration of an Amgen's KRAS product and will bethe lead for lifecycle management (LCM, Commercial) products, including determining regulatory reporting, and global filing requirements for post-approval variations related to synthetics (small molecule) products. The Manager will also facilitate communication of requirements and strategy to Process Delivery Team (PDT) in addition to the functional areas. The Manager will follow standard department and global marketing template processes to drive consistency across post approval programs.<br><br>Serve as Regulatory CMC voice for product teams by providing the following services:<br><ul><li>Define minimum regulatory filing requirements for post approval programs</li><li>Provide regulatory strategy through development of marketing application strategic plan and/or events</li><li>Global regulatory strategy</li><li>Development of post approval variations including maintenance of applications</li><li>Maintain product compliance through appropriate regulatory filings and activities</li><li>Support Change Management activities</li><li>Manageregulatory agency questions, commitments and periodic reports</li><li>Facilitate agency interactions, including meeting preparation, meetings and briefing documents</li><li>Ensure alignment with variation master plans, develop global implementation requirements, and implement changes throughout product life-cycles</li><li>Liaise with regional regulatory CMC counterparts and other functions within development, operations, and commercial to ensure alignment of globalregulatory strategies, timing, execution and plans</li><li>Contribute to the Product Delivery Teams Variation Master Plan</li><li>Maintain information for Center dashboards; and collaborate with other Centers to ensure information alignment</li><li>Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current</li><li>Participate as an active member of cross-functional teams including GRT, PDT, PQT, etc., as needed</li></ul><br><br><b>Basic Qualifications</b><br>Doctorate Degree<br>OR<br>Master's Degree and 3 years of Regulatory CMC or related technical experience<br>OR<br>Bachelor's Degree and 5 years of Regulatory CMC or related technical experience<br>OR<br>Associates degree and 10 years of Regulatory CMC or related technical experience<br><br>OR<br><br>OR<br>High school diploma / GED and 12 years of Regulatory CMC or related technical experience<br><br><b>Preferred Qualifications</b><br><ul><li>Degree in Life Science</li><li>Experience in Manufacture, Quality, Process Development or other related Pharmaceutical/Biotech industry</li><li>Regulatory CMC experience with small molecule and Biologic products</li><li>CMC-specific regulatory knowledge & experience</li></ul><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/k54j2rhNbk8Et7A8i4BJg"> <p>PI119187578</p>

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Posted: 2020-03-20 Expires: 2020-04-20

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Regulatory Affairs Manager, CMC

Amgen
Thousand Oaks, CA 91360

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