Regulatory Affairs Associate
Katalyst HealthCares & Life Sciences
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.
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Top Skills1.) 10+ years of Infrastructure Project Management experience in a global environment2.) Experience managing M&A or Divestiture related projects3.) Strong coordination, reporting, presentation, communication and follow up/tracking skills (PowerPoint, PowerBi, ...Contract workTemporary work- ...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
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...about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory...Full timeWork at officeLocal areaWorldwide$171.3k - $342.7k
...executives, and scientists The Opportunity The Director, Regulatory Affairs provides leadership, direction and support for regulatory... ...affecting the company through participation on trade associations and interfaces with regulatory agencies. This person will direct...- Connecting to a Career That Makes a Difference By submitting your application and selecting "Accept All", you confirm that you have read and understand this privacy statement and consent to the collection, use, and sharing of your personal information as described. Privacy...
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...Manages the Regulatory Operations team responsible for various operational regulatory activities. Oversee the preparation, review and... ...ease of regulatory agency review. Represents Global Regulatory Affairs at project meetings. Manages Regulatory Operation processes and...Work at officeLocal area- • Develops regulatory strategies for development projects, design changes and manufacturing improvements, and analyzes risk vs. benefit... ...industry experience with a minimum of five years in regulatory affairs with direct experience and authoring 510(k) and/or CE...
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