19 days old

Companion Diagnostic Regulatory Affairs Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114880571
Amgen

Job ID: R-85851
Location: Thousand Oaks, CA, US 91360

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

The Regulatory Affairs Manager will support in establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. The lead will also specifically develop and implement regulatory strategies and processes for in-vitro diagnostics (IVDs)/companion diagnostics (CDx's).

Responsibilities of the Regulatory Affairs, Manager include:
  • Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making.
  • Developing regulatory strategies for assigned products to enable timely registration of both therapeutic and diagnostic products by regulatory agencies.
  • Providing regulatory leadership and input to internal teams involved with IVD/CDX development planning, including Diagnostic Development Teams, and to Joint Development Teams with diagnostic partners.
  • Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks such as regulatory (e.g. PMA, 510(k), IDE) submissions.
  • In collaboration with diagnostic partners and internal teams, preparing for and executing meetings with regulatory agencies.
  • Review and approval of key regulatory submissions to CDRH (as agreed with diagnostic partners) and corresponding therapeutic dossiers.
  • Interacting with international regulatory colleagues and diagnostic partners to determine best practices & least burdensome regulatory paths towards development & global registration activities.
  • Assessing impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development & registration activities, respectively.
  • Regulatory support of due diligence activities of external CDx/IVD companies that Amgen may be considering as partners and other due diligence activities as needed.


Basic Qualifications:

Doctorate degree

OR
Master's degree and 2 years of Health Agency or Med-Device or Regulatory experience
OR
Bachelor's degree and 4 years of Health Agency or Med-Device or Regulatory experience
OR
Associate's degree and 10 years of Health Agency or Med-Device or Regulatory experience
OR
High school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experience

Preferred Qualifications:
  • MS Degree
  • Degree in Regulatory Affairs, Life Sciences, or Engineering
  • 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or combination product regulations
  • 8 plus years of experience in software development, medical device, IVD,companion diagnostics, and/orcombination product industry


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.

Amgen focuses on areas of high unmet medical needs 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.

PI114880571

<b>Amgen</b><br/><br/><b>Job ID: </b>R-85851<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Companion Diagnostic Regulatory Affairs Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: <br><br>The Regulatory Affairs Manager will support in establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. The lead will also specifically develop and implement regulatory strategies and processes for in-vitro diagnostics (IVDs)/companion diagnostics (CDx's).<br><br>Responsibilities of the Regulatory Affairs, Manager include:<br><ul><li> Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making. </li><li> Developing regulatory strategies for assigned products to enable timely registration of both therapeutic and diagnostic products by regulatory agencies. </li><li> Providing regulatory leadership and input to internal teams involved with IVD/CDX development planning, including Diagnostic Development Teams, and to Joint Development Teams with diagnostic partners. </li><li> Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks such as regulatory (e.g. PMA, 510(k), IDE) submissions. </li><li> In collaboration with diagnostic partners and internal teams, preparing for and executing meetings with regulatory agencies. </li><li> Review and approval of key regulatory submissions to CDRH (as agreed with diagnostic partners) and corresponding therapeutic dossiers. </li><li> Interacting with international regulatory colleagues and diagnostic partners to determine best practices & least burdensome regulatory paths towards development & global registration activities. </li><li> Assessing impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development & registration activities, respectively. </li><li> Regulatory support of due diligence activities of external CDx/IVD companies that Amgen may be considering as partners and other due diligence activities as needed. </li></ul><br><br>Basic Qualifications:<br><br>Doctorate degree<br><br>OR<br>Master's degree and 2 years of Health Agency or Med-Device or Regulatory experience<br>OR<br>Bachelor's degree and 4 years of Health Agency or Med-Device or Regulatory experience<br>OR<br>Associate's degree and 10 years of Health Agency or Med-Device or Regulatory experience<br>OR<br>High school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experience<br><br><b>Preferred Qualifications:</b><br><ul><li>MS Degree</li><li>Degree in Regulatory Affairs, Life Sciences, or Engineering</li><li>6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or combination product regulations</li><li>8 plus years of experience in software development, medical device, IVD,companion diagnostics, and/orcombination product industry</li></ul><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><b> Amgen </b> focuses on areas of high unmet medical needs 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>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/m6r1eOTbPzrLFKlqs4m2Z"> <p>PI114880571</p>

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Posted: 2019-10-25 Expires: 2019-11-25

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Companion Diagnostic Regulatory Affairs Manager

Amgen
Thousand Oaks, CA 91360

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