Regulatory Affairs Manager- Remote (China Regulations)

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timePosted 2 days ago location United States salarySalary undisclosed
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Job Description

We have a Contract role Regulatory Affairs Manager- Remote (China Regulations) our client Thousands Oaks, CA. Please let me know if you or any of your friends would be interested in this position.

The Position title:

Regulatory Affairs Manager- Remote (China Regulations) - Thousands Oaks, CA

Work Location: 1 Amgen Center Dr, Thousand Oaks, CA 91320/ Remote

Project Duration: 12 Months (High Possibility of Extension)

This particular role will focus on collaborating with Amgen's China partner, BeiGene, to develop diagnostic regulatory strategies that enable successful marketing authorization of diagnostics and therapies for patients in China.

Additionally, 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 clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities.

· Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development Teams, and to Joint Project Teams with diagnostic partners.

· Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions (e.g. PMA, 510(k), IDE).

· In collaboration with diagnostic partners and internal teams, preparing for and executing meetings with regulatory agencies.

· Review and approval of key diagnostic regulatory submissions to CDRH and global health authorities (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.

Preferred Qualifications

· MS Degree

· Degree in Regulatory Affairs, Life Sciences, or Engineering

· 6 plus years of experience in Regulatory Affairs, including China, United States and other international medical device and/or IVD/CDx regulations

· 8 plus years of experience in medical device and/or IVD/CDx industry

If you are interested in this opportunity, please email your resume at and include posting in your application. Also, you can call us at #and to discuss this position detail.

- provided by Dice