Regulatory Affairs Senior Manager- Companion Diagnostics
Job Function: Quality/Regulatory
Travel Required: Yes, 10% of the Time
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
Be a part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to labs, partners and patients globally.
In the Companion Diagnostics Business (CDx), our team partners very closely with leading pharmaceutical companies to develop, manufacture and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients.
Become a part of a growing and dedicated team that does truly inspiring work in the field of Precision Medicine. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer.
This is an exciting opportunity to be part of a growing team with proven record of success in global registrations in Companion Diagnostics in the field of Oncology.
In this role you will have opportunity to closely work with the group of approximately 20 Regulatory Affairs and Quality Design Assurance professionals, managing 3-6 direct reports. Staff members are located in US, China, Japan and EU. The successful candidate must be a strategic thinker, able to evaluate and act on various complex scenarios involving co-development programs of drug and diagnostics, with ability to manage aggressive timelines. Besides strong regulatory affairs expertise in IVD's, the successful candidate is also a strong people manager, able to work with the Director of this group to ensure all Regulatory Affairs and Quality Design Assurance systems are established, implemented, and maintained in accordance with applicable standards for the company.
In this role, the ideal candidate
Works closely with CDx functional heads in establishing and implementing CDx business and strategic goals
Develops and implements strategies for timely submission and approval of regulatory submissions for Companion/Complementary Diagnostic products
Interacts and collaborates with pharmaceutical partners in drug and diagnostic co-development programs
Ensures the accurate and timely preparation of regulatory submissions and reporting in accordance with company goals, regulatory requirements and partnership contracts
Interacts with the FDA and other regulatory agencies in connection with submission, approvals, and audits
Participates in Joint Steering Committees and Joint Project Teams as the senior representative of regulatory affairs in the Companion Diagnostics division
Prepares and presents project status reports, strategy and initiatives to CDx leadership teams, Sr. DGG staff, as it relates to regulatory affairs
Works across Agilent DGG in formulating regulatory processes/procedures and shares best practices/knowledge with regulatory colleagues across Agilent
Stays abreast of global IVD regulations and guidance's, especially those relevant to Companion Diagnostics
- Bachelors or Master Degree or University Degree or equivalent in a related field preferred biological or molecular sciences
- Advanced degree or regulatory affairs certification preferred, directly relevant experience as a manager, supervisor preferred
- Minimum 7+ years Regulatory experience in IVD and/or medical device environment
- Proven ability to lead regulatory teams to success
- Direct experience with national and international regulatory registrations, submission, regulations, and developing effective relationships with regulatory agencies
- Experience in Companion/Complimentary Diagnostics, and has lead company-sponsored interactions with regulatory bodies, especially FDA
- Excellent English oral and written communication skills
- Strong technical/scientific background
- Experience with worldwide regulatory submissions and approvals in the area of in vitro diagnostics (IVD) Class III (PMAs), preferably Companion Diagnostics and Molecular Technologies
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
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Option to Work Remote: Yes