Senior Regulatory Affairs Leader — NDA/ANDA Submissions
JobRx, Inc.
LGM Pharma is seeking a Senior Regulatory Affairs Specialist to oversee the ANDA/NDA submission processes for regulatory compliance. The ideal candidate will have at least 10 years of experience in regulatory affairs within the pharmaceutical industry and a Bachelor's degree in a science field. Responsibilities include preparing compliance documentation, interacting with regulatory agencies, and ensuring timely submissions. LGM Pharma values its employees and offers benefits including health insurance and a 401K match. #J-18808-Ljbffr JobRx, Inc.
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A leading dental products company located in California is seeking a Regulatory Affairs Specialist to prepare and submit product registrations, maintain company registrations, and analyze compliance metrics. The ideal candidate will have at least 5 years of experience...Senior- A global pharmaceutical company is seeking an Associate Director of Regulatory Affairs in Irvine, CA. This role focuses on preparing regulatory strategies and submissions for CMC, managing team relationships, and serving as a liaison with regulatory agencies. The ideal...Senior
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Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for product lifecycle activities based in Irvine... ...guidance for product compliance, preparation and submission of regulatory documentation, and oversight of product labeling...Senior- A reputable medical devices company is seeking a Senior Regulatory Affairs Coordinator for an onsite position in Irvine, CA. The role involves supporting US and EU regulatory submissions, developing regulatory strategies, and providing guidance on registration. Candidates...SeniorContract workWork at office
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...Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a direct hire opportunity with... ...Planning and Regulatory Support Lead the submission, approval, and lifecycle management for both ANDA and NDA filings. Contribute to the development,...Senior$83.9k - $120k
A leading healthcare technology company in Irvine, California is seeking an experienced Regulatory Affairs professional. This role involves preparing and submitting product registrations, maintaining compliance with federal and state regulations, and managing audits. Applicants...Senior- Parker Hannifin is seeking a Contracts Manager in Irvine, CA to lead strategic negotiations and manage complex government contracts critical to Military business success. You will oversee contract performance, negotiate terms, and develop proposals while ensuring compliance...SeniorContract work
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CPT Group, Inc. is looking for a Full-Time Senior Human Resources Manager based in Irvine, CA. This on-site role involves leading HR initiatives, managing employee relations, and aligning HR strategies with the company's values. Candidates should possess a Bachelor’s degree...SeniorFull time- EY in California is seeking a Real Estate Tax Senior Manager to lead complex tax planning projects and provide expert tax advice to a diverse client base. You will supervise a motivated team, ensuring their development while leveraging your extensive tax knowledge to address...Senior
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Edwards Lifesciences in Irvine, California is looking for a Regulatory Affairs specialist to support product development and compliance... ...representing the regulatory function on development teams, preparing submissions for global regulatory agencies, and ensuring documentation...Senior$92k - $130k
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Edwards Lifesciences in California is seeking a Regulatory Affairs professional, with a Bachelor’s Degree and at least 8 years of related... ...regulatory functions on product development teams, preparing submissions for global regulatory agencies, and ensuring compliance...- ...Job Title Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within... ...Participate in the preparation and submission of regulatory documents related... ...of experience in regulatory affairs within the pharmaceutical or...Senior
- ...Position : Senior Regulatory Affairs Specialist Location : Irvine, CA Duration : 10 Months Total Hours/week : 40.00 1st Shift Client... ...for planning, coordinating and implementing regulatory Submissions for products that require government approval. Demonstrates...SeniorContract workDay shift
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Boston Scientific is seeking a Senior Regulatory Affairs Specialist to join our team in Irvine, CA. The role involves supporting regulatory compliance and submissions for our active implantable device portfolio. Candidates should have a Bachelor's Degree in a scientific...Senior- A medical devices company is seeking a Senior Regulatory Affairs Coordinator in Irvine, CA. The role involves supporting US and EU regulatory submissions, developing regulatory strategies, and providing guidance on registration requirements. Candidates should possess a...SeniorWork at office
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