Senior Associate, Regulatory Affairs CMC
Gilead Sciences, Santa Monica, CA, United States
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
Kite’s Regulatory CMC team is hiring a Senior Associate. This is an individual contributor role.
Job Responsibilities
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Responsible for preparing moderately complex regulatory submissions which require interactions with departments outside of Regulatory Affairs CMC for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures
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Supports operational and life cycle management of regulatory CMC submissions in support of global commercial and clinical programs.
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Identify CMC risk areas and suggest alternative scenarios and course of action
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May act as Regulatory CMC representative on cross functional project teams by applying knowledge of regulations and interprets technical regulatory guidelines to ensure that regulatory submissions are in compliance with applicable regulations
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May be responsible for ensuring that CMC-specific registered technical details are updated and maintained
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Responsible for development and acquisition of required regulatory skills and knowledge, under guidance of immediate manager
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May initiate or contribute to local process improvements as they relate to Regulatory Affairs CMC function
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Participates in group meetings and presents project status updates and strategic approaches to moderately complex programs
Basic Qualifications
Master’s and 3+ years of regulatory or biopharmaceutical industry experience
OR
Bachelor’s and 5+ years of regulatory or biopharmaceutical industry experience
OR
Associate and 7+ years of regulatory or biopharmaceutical industry experience
OR
High School Diploma/GED and 9+ years of regulatory or biopharmaceutical industry experience
Preferred Qualifications
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2+ years relevant experience in Regulatory Affairs CMC and/or biopharmaceutical industry
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Some knowledge of ICH requirements, and an understanding of current global trends in CMC Regulatory Affairs
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Organizational skills – detail oriented and able to adapt to frequent changes in product activity
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Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
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High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
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Self-motivated with a strong sense of ownership in areas of responsibility
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High degree of professionalism, ethics and integrity
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Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.
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The salary range for this position is: $112,710.00 - $145,860.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
Change The World With Us
Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.
While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.