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job summary: Immediate opportunity for a Sr. Regulatory Affairs Associate, CMC to assist the technical team in preparing regulatory filing dossiers, assess changes for regulatory impact, and manage documentation systems. You will participate in Global Regulatory Product Team (GRPT) and Operations Brand Team meetings as needed. As a Senior Associate, RA CMC, you will work with internal and external partners in order to deliver products to patients. Prepare CMC regulatory strategies that enable first pass approvals under management supervision. Develop and manage content strategy for regulatory submissions, including INDs / CTAs and amendments, new market applications and supplements / variations under management supervision. 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.   location: North Chicago, Illinois job type: Contract salary: $35.00 - 41.49 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Prepare CMC regulatory submissions under management supervision. Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements, and variations under management supervision.Analyze and interprets information, that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.Review and revises regulatory submissions to effectively present data and strategy to regulatory agencies under management supervision.Respond to global regulatory information requests under management supervision and regularly informs regulatory management of important timely issues.Manage products and change control with an understanding of regulations and company policies and procedures under management supervision. Analyzes and approves manufacturing change requests under management supervision.May represent CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.Stay abreast of regulatory procedures and changes in the regulatory climate. Maintain awareness of legislation and current developments within specific area of business  qualifications: Bachelor's degree (BA / BS) in Pharmacy, Biology, Chemistry, Pharmacology, Engineering or related subject Four (4) or more years pharmaceutical or industry related experience.One (1) - two (2) years in quality systems or cross functional project managementExperience working in a complex and matrix environmentStrong oral and written communication skills Preferred Skills and Experience: Advanced degree preferred. Certification a plus.Five (5) years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing  skills: CMC, Regulatory Affairs Operations, Regulatory Briefing Documents, Submissions, ICH Regulations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). This posting is open for thirty (30) days.

Ready for great manufacturing, warehouse or industrial job opportunities? Take the first one by joining our team and finding your next growth opportunity in a safety- and team-oriented warehouse environment. Specifically, we're hiring skilled production associates who enjoy working with their hands or simply dependable employees who are looking to learn a new trade. No previous experience is required for most of these roles. If that sounds like you, click to apply today!job summary:Randstad is seeking motivated and reliable Entry-Level Manufacturing Associates to join our team at Flextronics! This is a great opportunity to jumpstart your career in manufacturing and gain hands-on experience in a fast-paced environment. As a Manufacturing Associate, you'll play a key role in supporting production by ensuring machines are loaded and monitored effectively. Key Responsibilities: Load trays of product and boxes into machines to maintain steady production flow. Monitor the production line and ensure machinery is running smoothly. Quickly identify and respond to alarms or errors by notifying maintenance or supervisors. Work collaboratively with the production team to meet daily goals and ensure product quality. Qualifications: High school diploma or GED. Ability to lift and move trays and boxes as needed. Strong attention to detail and alertness to monitor production closely. Comfortable working 12-hour shifts in a standing position. Why Join Us? Gain valuable experience in the manufacturing industry. Opportunity for growth and development with a well-established company. Comprehensive training provided - no prior experience necessary. Increase in pay at 3 month and 9 month period. 3 month- $20.90/hr 9 month- $22.50/hr If you're a team player with a strong work ethic and a desire to grow in manufacturing, apply today to join the Randstad team at Flextronics!location: Buffalo Grove, ILsalary: $19/hrwork hours: 06:00 PM - 06:00 AMdress code:Shirts or t-shirts must have sleeves and be without any holes or rips. Pants without any holes or rips. No profane or suggestive texts and images. Closed toe and non slip footwear only. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.

Ready to take advantage of growth opportunities at some of the top companies in your area? Reliable production associates who are comfortable working in high-speed environments and motivated by overtime pay should be sure to apply. Read on for more information. The application process itself only takes a moment, and if you're qualified, we'll get back to you promptly.job summary:As a production associate, you will be assembling ingredients into trays for production, dumping ingredients, packaging finished product. You will operate and maintain machinery to ensure production standards are met then finalize products and prepare them for shipping. Must be able to work in cold environment. location: Schaumburg, ILsalary: $18/hrwork hours: 05:00 AM - 02:00 PMdress code:Shirts or t-shirts must have sleeves and be without any holes or rips. Pants without any holes or rips. No profane or suggestive texts and images. Closed toe and non slip footwear only. No jewelry. Fake nails or fake eyelashes. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.