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.
This is an exciting opportunity to be part of a growing team with a proven record of success in Companion Diagnostics IVDs in the field of Oncology.
In this role, you will have direct responsibility for approximately 20 Regulatory Affairs and Quality Design Assurance professionals, as well as dotted-line oversight of Clinical Operations and Clinical Affairs, managing 5-6 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 the ability to manage aggressive timelines. Besides strong regulatory affairs expertise in IVDs, the successful candidate is also a strong people manager and an excellent collaborator.
Reporting to the VP and General Manager of Companion Diagnostics, a business within the Diagnostics and Genomics Group of Agilent Technologies, the Director will oversee and be responsible for all regulatory activities for new and existing CDx projects/products to ensure successful project registrations/approvals and compliance with local, regional and global registration requirements as well as with company policies. The Director directs the group and activities to ensure all Regulatory Affairs and Quality Design Assurance systems are established, implemented, and maintained in accordance with applicable standards for the company.
Major Responsibilities • Develops and implements strategies for timely submission and approval of world-wide regulatory submissions for Companion/Complementary Diagnostic products. • Works closely with CDx functional heads in establishing and implementing CDx business and strategic goals.
• 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.
• Works across the organization to ensure alignment of regulatory processes, standards and compliance. • Interacts with regulatory agencies at all levels, e.g. audits, submission reviews. • Establishes operational objectives, work plans, and delegates assignments to subordinate managers and staff • Represent the company in 3rd party meetings, especially the FDA, and regulatory associations.
• Stays abreast of global IVD regulations and guidance's, especially those relevant to Companion Diagnostics.
Required Education, Experience, Skills
• Bachelors or Master Degree in related field, preferred biological or molecular sciences, plus 5-7 years of relevant experience as a first level and second level manager
Experience/Skills: • 10 years of Regulatory experience in a medical device environment preferred; Regulatory affairs certification preferred • Demonstrated strong management and leadership skills in implementing program/organization strategies • Proven ability to lead regulatory teams to successfully develop and execute regulatory and business strategic initiatives • Experience with worldwide regulatory submissions and approvals with in vitro diagnostics (IVD) Class III (PMAs), preferably Companion Diagnostics and Molecular Technologies • Direct experience with national and international regulatory registrations, submission, regulations, and developing effective relationships with regulatory agencies required • Experience in Companion/Complementary Diagnostics having led company-sponsored interactions with regulatory bodies, especially the FDA, preferred • Demonstrated ability to effectively communicate and influence across all levels of an organization • Excellent interpersonal, communication and collaboration skills • Excellent English oral and written communication skills • Strong technical/scientific background
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.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster available here: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf,
Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1-262-754-5030 (US and Canada only) or email email@example.com. EOE AA M/F/Vet/Disability
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.