Irvine, California, United States · On-site
$161k–$305k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: CMC Regulatory Strategy, Regulatory Submissions, IND/CTA Applications, Agency Interaction, Life-cycle Management
Irvine, California, United States · On-site
$32/hr–$39/hr
Regents Point, a premier 5-star HumanGood life plan community (CCRC) in Irvine, CA, is seeking a dedicated and experienced professional to join our team as a full-time Nutrition Services Supervisor. Under general supervi…
Skills: Interpersonal Communication, Computer Proficiency, Problem Solving, Record Keeping, Team Supervision
Irvine, California, United States · Hybrid
$89k–$106k/yr
Social Media Manager (Hybrid - 4-5 days per week onsite) Overview: The Sport & Entertainment Social Media Manager will lead and execute the social media strategy for the Sports & Entertainment vertical as part of the Mar…
Skills: Social Media Strategy, Content Calendar Management, Community Engagement, Short-form Video Production, Real-time Event Coverage
Irvine, California, United States · On-site
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Event Coordination, Program Planning, Administrative Support, Student Engagement, Time Management
Irvine, California, United States · On-site
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Surgical Care Management, Patient Assessment, Clinical Judgment, Operating Room Assistance, Medical Documentation
Irvine, California, United States · On-site
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Inpatient Care Management, Surgical Consultations, Patient Assessment, Treatment Planning, Clinical Judgment
Irvine, California, United States · On-site
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Inpatient Care Management, Surgical Consultations, Patient Assessment, Treatment Planning, Clinical Judgment
Irvine, California, United States · On-site
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Surgical Care Management, Patient Assessment, Clinical Judgment, Operating Room Assistance, Medical Documentation
Irvine, California, United States · On-site
Join the leading beverage provider, Reyes Coca-Cola Bottling! Benefits: Medical, Dental, Vision, 401K Match, Paid Time Off, Education ReimbursementSalary: $140,120 - $175,150 plus annual target bonus If you enjoy our pro…
Skills: Financial Analysis, Equipment Inventory Management, ROI Assessment, Performance Accountability, Team Leadership
Irvine, California, United States · Hybrid
$120k–$180k/yr
Description You’ll Come for a Job…But You’ll Stay for an Exciting Career!Engineering and Designing Reliable, Responsive, Solutions. SINCE 1976, CANNON has provided creative solutions to clients in the energy industry, wa…
Skills: Electrical Design, Power Systems Engineering, Low Voltage Design, Medium Voltage Design, Project Management
Irvine, California, United States · Hybrid
$61k–$77k/yr
About Multi Media, LLC Multi Media, LLC is the company behind Chaturbate, one of the most heavily trafficked live streaming platforms in the world. We support a global network of independent content creators and millions…
Skills: MacOS Support, Windows 10 Support, ChromeOS, iOS, Linux
Irvine, California, United States · Hybrid
$110k–$130k/yr
Company Description About SOCOTEC: SOCOTEC is a provider of niche consulting services within the architecture, engineering and construction industries focusing on high-performance buildings and specialty structures. Thro…
Skills: Hazardous Building Materials Consulting, Asbestos Abatement, Lead-Based Paint Investigation, Regulatory Compliance, Technical Writing
Irvine, California, United States · On-site
$75k–$92k/yr
Are you ready to join a growth-oriented team where creativity meets innovation? At Ware Malcomb, we are a dynamic and forward-thinking design firm committed to pushing the boundaries. Our team-oriented, collaborative app…
Skills: Multi-state Payroll, HRIS, Payroll Tax Filing, Auditing, Payroll Compliance
Irvine, California, United States · On-site
$127k–$150k/yr
CURRENT EMPLOYEES, CONSULTANTS, AND AGENCY PARTNERS: If you currently work for Brown-Forman, please apply by clicking the Careers icon on the Workday portal. For best results, use Google Chrome to view this page. Meaning…
Skills: Financial Leadership, Strategic Planning, Business Analytics, Pricing Strategy, Discount Management
Irvine, California, United States · On-site
$185k–$215k
Job description: Aperto Property Management, Inc. (Aperto), is more than just a property management company. We are a full-service, fee-based apartment management company for conventional and affordable multi-housing com…
Skills: Financial Strategy, Multifamily Finance, GAAP Compliance, Budgeting and Forecasting, Cash Flow Management
Irvine, California, United States · On-site
$185k–$215k
Job description: Aperto Property Management, Inc. (Aperto), is more than just a property management company. We are a full-service, fee-based apartment management company for conventional and affordable multi-housing com…
Skills: Financial Strategy, Multifamily Finance, GAAP Compliance, Budgeting and Forecasting, Cash Flow Management
Irvine, California, United States · On-site
$23/hr–$34/hr
About ITT: ITT Inc. (NYSE: ITT) is a diversified global leading manufacturer of highly engineered critical components and customized technology solutions serving the flow, aerospace and defense, transportation, industria…
Skills: Electrical Connector Assembly, Cable Assembly, Soldering, Crimping, Mechanical Assembly
Irvine, California, United States · On-site
$23/hr–$34/hr
About ITT: ITT Inc. (NYSE: ITT) is a diversified global leading manufacturer of highly engineered critical components and customized technology solutions serving the flow, aerospace and defense, transportation, industria…
Skills: Electrical Connector Assembly, Cable Assembly, Soldering, Crimping, Mechanical Assembly
Irvine, California, United States · Remote OK
$154k–$204k/yr
Meet the Moment with Alteryx We're living through a once-in-a-generation shift in how work gets done. Data, automation, and AI are quickly becoming the center of every business decision - and Alteryx is leading the trans…
Skills: Salesforce CRM, CPQ, Service Cloud, Partner Portal, Enterprise Architecture
Irvine, California, United States · Remote OK
$60k–$80k/yr
Overview Workers' Compensation Claim Representative IILocation: Irvine, CA - reporting remotelySchedule: 8:00am - 4:30pm (PST)Salary Range: $60,000 - $80,000 (depending on experience) Build Your Career With Purpose at CC…
Skills: Workers' Compensation Claims Management, Claim Investigation, Indemnity Calculations, Settlement Negotiation, Subrogation
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The Director of RA CMC develops and manages regulatory strategies and submissions for product approvals and life-cycle management. They serve as the primary strategic liaison with regulatory agencies like the FDA and lead cross-functional teams in R&D and Operations.
Requires a Bachelor's degree in a scientific or engineering field with at least 10 years of biopharmaceutical experience, including 5+ years in Regulatory Affairs. Candidates should have a proven track record of leading global regulatory strategies and interfacing with government agencies.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers and management in RA, R&D, and Operations. Serves as strategic liaison with regulatory agencies (e.g., FDA) regarding CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Allergan is now part of AbbVie. AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
