AVP, Global Regulatory Affairs, CDx

Job Description

Agilent inspires and supports discoveries that advance 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.

Reporting to the Vice President of Global Regulatory Affairs (GRA), the Associate Vice President (AVP) of Companion Diagnostics (CDx) Global Regulatory Affairs is responsible for providing regulatory oversight to Companion Diagnostic regulatory affairs activities, including those of Agilent Resolution Bioscience, in the Diagnostics & Genomics Group (DGG) at Agilent.

This position will partner with DGG Global Quality and Regulatory Affairs (GQRA) colleagues and the CDx leadership team to establish regulatory strategies and provide input to the CDx business, support CDx projects and business objectives, and partner on the execution of regulatory responsibilities, in accordance with global regulations and standards. The person will be a member of the CDx leadership team, representing Regulatory Affairs.

The leader will be a member of the DGG Global Regulatory Affairs leadership team and interface closely with GQRA leadership. This leader will also manage a team of direct and indirect reports and will periodically travel to support CDx business objectives. Key responsibilities include:

• As business leadership team member, working with other functional leads on the strategic planning for the CDx business, representing regulatory.

• Works closely with CDx functional heads in establishing and implementing CDx business and strategic goals.

• Develops and partners to implement regulatory strategies and partners with the Global Regulatory team 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.

• Partners with development and clinical teams to ensure the timely and compliant generation of clinical and validation data required to support regulatory submissions for all new products and modifications to existing products.

• Ensures regulatory submissions are reported in accordance with company goals, regulatory requirements, and partnership contracts.

• Interacts with the FDA and other regulatory agencies in connection with premarket product approvals.

• Provides regulatory oversight throughout product lifecycle.

• Actively manage departmental budget to meet strategic goals.

• Participates in Joint Steering Committees and Joint Project Teams with pharma partners as the senior representative of regulatory affairs in the Companion Diagnostics division.

• Establishes active dialogues with global health authorities, customers, distributors, pharma partners, and colleagues globally while representing the diagnostic market.

• Provides leadership for the DGG GQRA and DGG GRA organizations, supporting DGG strategic initiatives collaborating with other DGG divisions.

• Prepares and presents project status reports, strategies, and initiatives to CDx leadership teams and Sr. DGG staff.

• Works across Agilent DGG in formulating regulatory processes/procedures and sharing best practices/knowledge with regulatory colleagues across Agilent.

• Stays abreast of global IVD regulations and guidance, especially those relevant to Companion Diagnostics. Influences new regulatory policy as the science and technology advances in Companion Diagnostics.

• Creates and executes the strategic direction for the Companion Diagnostics Global Regulatory Affairs organization, and assists in the creation and execution of Agilent’s overall Global Regulatory Affairs strategy.

• Managing and developing regulatory affairs talent within the Companion Diagnostics Global Regulatory Affairs organization.

#LI-PK1

Qualifications

Education:

• Bachelors or master’s degree or University Degree or equivalent in a related field, preferred biological or molecular sciences

• Advanced degree or quality or regulatory affairs certification preferred, directly relevant experience as a manager, supervisor preferred

Experience:

• Minimum of (8+) years of regulatory leadership roles of increasing responsibility in in vitro diagnostics.

• Experience in companion/complementary diagnostics and liquid biopsy and has led company-sponsored interactions with global regulatory bodies, especially FDA.

• Regulatory experience in notified body interactions and leading conformity assessments.

• Experience with worldwide regulatory submissions and approvals in in vitro diagnostics (IVD) Class III (PMAs), preferably companion diagnostics, liquid biopsy and molecular technologies.

• Direct experience with national and international regulatory registrations, submission, regulations, and developing effective relationships with regulatory agencies.

• Demonstrated track record of results using interpersonal, relationship-building skills required to lead multi-cultural and geographically dispersed teams in a fast-paced, highly matrixed environment

• Demonstrated experience in engaging pharma partners in Companion Diagnostic collaborations.

Personal Characteristics

• Transformational leader who brings intensity & excitement everyday

• Passionate, visionary thinker with a desire to excel and inspire others

• High degree of self-awareness and emotional intelligence

• Creative thinker willing to explore unique, out-of-the-box solutions

• Ability to bring research use only and in vitro diagnostics products to market efficiently through business collaborations and effective regulatory strategies

• Ability to weave complex concepts into a clear compelling message

• Excellent collaboration, influencing and facilitation skills

• Pragmatic and customer focused

• Ability to identify and focus on key priorities

• Self-starter, self-reliant, courage of conviction

• Willingness to travel globally on a regular basis.

• Willingness to engage teams and business partners across multiple time zones.

The US pay range for this full-time position is $171,600.00 - $308,344.00/yr, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Additional details are available at: https://careers.agilent.com/locations/americas/united-states/

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.

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 email job_posting@agilent.com or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please see all of our notices for EEO below.

Option to Work Remote

Yes

Travel Required

25% of the Time

Shift

Day

Duration

No End Date

Job Function

Quality/Regulatory