VP, Legal (Regulatory Affairs)

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

VP, Legal - US1

Summary

Responsible for setting Legal vision, mission and strategy for Regulatory Affairs. Evaluates, directs strategy and manages complex internal and external legal issues, regionally and globally, in collaboration with management and outside counsel.

Key Responsibilities

• Working directly with clients, provide strategic and practical legal counsel on a wide variety of drug and medical device development legal and regulatory issues.

• As a strategic partner, work to identify and advise on business and regulatory issues with important legal implications both independently and as part of a larger, global legal team.

• Collaborate with internal clients and Legal Department colleagues in different countries and across departments.

• Create and maintain a positive leadership image, providing strategic direction, positioning and effective communication/partnering to a team of legal professionals, including attorneys, paralegals and administrative support.

• Act as a strategic key point of contact for Legal advisory services for all regions (AMR, EMEA & APAC overflow), exercising significant influence with executive leaders. Serves as the internal legal expert but also external expert by maintaining influential outside contacts such as vendors and professional associations.

• Provides legal counsel to the highest executive levels regarding best practices, strategic advisement with respect to mitigating risk and to ensure legal compliance for Illumina. Provides strategic direction and legal counsel to all other levels with respect to Regulatory Affairs.

• This position will be remote, in Washington, D.C. and will report to the General Counsel who is located at Illumina headquarters in San Diego, CA. The V.P., Legal, Regulatory Affairs will have 1 direct report, a Sr. Director, Legal, Regulatory Affairs.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Qualifications Minimum Requirements

• J.D. degree or LL.M. degree from an ABA accredited law school, admission to practice law in a U.S. jurisdiction and at least 15 years of experience practicing law.

• 15+ years of experience as an attorney in a large law firm, biopharmaceutical company, or in a major government agency practicing law related to biotechnology, pharmaceutical, medical device and/or healthcare.

• Experience working with the FDA and the laws and regulations relating to the discovery, development, approval, sales & marketing of biotechnology/pharmaceutical/medical device products (including federal and state anti-kickback and healthcare/fraud and abuse laws).

• Experience with clinical and consultant contracts, and/or products liability.

• Excellent interpersonal skills.

• Ability to handle, prioritize and follow through on diverse issues on a timely basis.

• Resourceful and able to participate in highly collaborative, cross-functional team-oriented environment.

• Ability to meet demanding deadlines.

• Strong research and writing skills.

• Manage multi-dimensional projects in fast paced environment.

The estimated base salary range for the VP, Legal - Regulatory Affairs role based in the United States of America is: $273,400 - $410,000. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. This role is not eligible for visa sponsorship.