Regulatory Affairs Associate
Katalyst HealthCares & Life Sciences
Job-ID32457737Reference26-00999Remote50% Remote Responsibilities: Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU Create and maintain regulatory records, including: Product registrations Approval and renewal updates Indication and packaging changes Commitment and obligation tracking Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets. Monitor submission and approval activities to maintain data integrity and compliance. Support audit and inspection requests related to regulatory submissions and approvals. Participate in monthly quality control reviews, identify data gaps, and support remediation efforts. Assist with system enhancements, upgrades, and continuous process improvement initiatives. Requirements: Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related discipline Experience or exposure to Regulatory Data Management Familiarity with Veeva systems Strong written and verbal communication skills High attention to detail and an interest in global regulatory processes Why This Opportunity Stands Out Whether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment. Interested or know someone who would be a great fit? Reach out today.
- Job-ID32908843Reference26-01550 Summary: The Manager, Process Excellence within Regulatory Affairs is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations....Suggested
- ...Other Related Subject 2. 2-4 years CMC Regulatory experience - Bachelors Degree: Chemistry... ...Operations Brand Teams as needed The Senior Associate, RA CMC works with internal and external... ...relationships within the Regulatory Affairs functional areas and the Operations and...SuggestedRemote work
- ...Reference26-00999Remote50% Remote Responsibilities: Support regional Regulatory Information Management (RIM) activities using systems such as... ...initiatives. Requirements: Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related discipline Experience...SuggestedRemote work
- ...of planned submissions and approvals in a region to: Supports regulatory information management activities in the region focusing on... ...Correspondence/responses from agency are imported into Cosmos in association with relevant activity Response structures linked to relevant...SuggestedLocal area
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$61.3k - $122.7k
...for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity The Regulatory Affairs Specialist II (Medical Events) position supports the Infectious Disease business in Lake Forest, IL on site. Our diagnostic...Worldwide$35 per hour
...Advance your career with a Top-Tier Global Pharma Leader in North Chicago, IL! This exciting 2-year hybrid contract role as a Regulatory Affairs Associate II offers the opportunity to drive CMC regulatory strategies and prepare high-impact submission dossiers for globally...Hourly payContract workTemporary workWork experience placement- The Visual Pak Companies is seeking a Site Safety Coordinator in Waukegan, IL to support and maintain workplace safety programs at the site. You will assist with action items, inspections, and compliance under the EHS department guidance. Responsibilities include safety...
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...along with administering the fiduciary account program. ESSENTIAL FUNCTIONS: Ensures compliance with all state and federal regulatory requirements including, but not limited to, Anti-Money Laundering, OFAC, BSA, GLBA, HMDA, Reg CC, Reg D, Reg E, Reg Z, Truth in...Local area- One Federal Solution seeks Credentialing Specialists to support a large federal identity credentialing program. The Credentialing Specialist will perform credential enrollment, issuance, activation, inventory management, and customer support activities while ensuring compliance...
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$97.5k - $139.75k
Position Summary Provides regulatory support and expertise associated with global and US registration of medical device products, including in-depth analysis... ...agency review. Represents Global Regulatory Affairs at research and development meetings and presents agreed...Work at officeLocal area$78k - $156k
...expert to assure successful investigations and corrective actions . Serves as a source of information on the IT Compliance needs and regulatory environment. What You?ll Work On Leads the IT Compliance activities for specific CAPA (Corrective and Preventive Action) event...Worldwide- An established industry player is seeking a detail-oriented logistics coordinator to manage import/export processes. This role involves supporting internal customers with shipment coordination, ensuring compliance with U.S. regulations, and maintaining accurate documentation...
- ...distributor of shipping, industrial and packaging materials, and we’re growing! As an International Trade Compliance Specialist, tackle regulatory hurdles, find tariff savings and bring Uline’s high quality products to international destinations. Careers Packed with Potential...
- ...please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately complex submission projects involving multiple cross-...Temporary workWork at officeLocal areaRemote work
- ...YouTube. Job Description The Senior Associate, RA CMC is responsible for ensuring RA-... ...functional departments in support of regulatory filings. Responsibilities: Manage,... ...experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or...Full timeTemporary workWork at officeLocal areaRemote work
- ...operational effectiveness across the portfolio. Responsibilities: Ensure compliance with applicable corporate, organizational, and regulatory policies and procedures. Build and maintain relationships across BTS and business functions. Work with compliance leads to...Full timeTemporary workLocal area
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- AbbVie in North Chicago, IL is seeking a Business Compliance Liaison for Development Sciences to ensure GxP compliance across research and development activities. You will collaborate with Dev Sci, QA, and Operations, supporting document management, quality systems, and...
- Abbott, a global healthcare leader, seeks a Regulatory Affairs Specialist II (Medical Events) in Lake Forest, IL on site. You will review and submit Medical Device Reports (MDRs) and vigilance reports, ensuring compliance with 21 CFR 803 and related regulations. You will...
$20 - $24 per hour
Pay : $20.00 - $24.00/HR based on experience! Duration : 1-year contract (potential to extend/convert based on performance/budget) Location : 100% onsite; M-F 8:30 AM - 5:00 PM Responsible for: Support internal customers in coordinating the inbound and outbound shipment...Contract work- Data AnalystCorporate Headquarters12575 Uline Dr. Pleasant Prairie, WI 53158Ready to make a real impact? Join Uline as a Data Analyst to be a driver of operational excellence. From searching for improvements regarding manual processes to thinking critically about various...Full time
- ...Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market... ...communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial....Local area
- ...efficiencies. Act as a trusted source for trade compliance insights by proactively tracking, interpreting, and communicating regulatory and legislative updates to GTC stakeholders—ensuring the organization stays ahead of potential impacts with timely and actionable...Full timeTemporary workLocal areaWorldwide
$123k - $205.1k
...export and sanctions compliance program to include policies, procedures, and controls tailored to the company's risk profile and regulatory requirements. Function as a hands-on operational leader for export and sanctions compliance, providing timely review and resolution...Full timeWork at officeLocal areaWorldwide3 days per week
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