Documentation: Write, analyze, and edit technical documents to support country-specific Regulatory submissions. Regulatory..., Canada, Europe, and other countries. Regulatory Files: Create, maintain and update Regulatory authorizations, such as 510...
organization's ongoing relationships with regulatory commissions/authorities. Coordinates and conducts the assessment of internal... controls to ensure compliance as required by regulatory commissions/authorities. Develops programs and processes to manage...
and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States... and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards. Key...
and ethical considerations. Provides regulatory protocol training. Crafts and distributes applicable regulatory documents...
and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States... and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards. Key...
Overview With minimal supervision, responsible for coordination and preparation of document packages for regulatory... and recommends changes for labeling, marketing literature and clinical protocols for regulatory compliance to international...
Responsibilities: The Associate Principal Scientist is responsible for developing CMC regulatory submission... of regulatory CMC dossiers for new and existing commercial products. Work independently and effectively to manage and author...
(DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings...
Responsibilities: Complete and maintains regulatory approvals/clearances of heart valve replacement and repair... devices, Represent the Regulatory function on manufacturing and product development teams to provide input on regulatory...
Responsibilities: Regulatory Submission: Prepare and submit documents to regulatory authorities, including... between regulatory bodies, clinical teams, and external stakeholders to facilitate communication and address any compliance issues...
About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the fo...
About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the fo...
Job Title: Regulatory Affairs Specialist with QA Experience Looking for someone with at least 2 years of Regulatory... and QA experience. Job Description We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist...
Regulatory Affairs, Project Manager - Contract - Remote, Indianapolis Proclinical is looking for a detail-oriented... communication and interpersonal skills for interacting with cross-functional teams and stakeholders. The Regulatory Affairs...
Indianapolis, USA Posting date: 05 Feb 2025 Reference: 64128 Regulatory Affairs, Project Manager - Contract - Remote... teams and stakeholders. The Regulatory Affairs, Project Manager's responsibilities will be: Regulatory Landscape...
. We are looking for a driven and motivated Global Regulatory Affairs Director who will be instrumental in developing and executing global... or healthcare science Minimum of 5+ years of experience in pharmaceutical industry Regulatory Affairs Minimum of 2 years...
Opportunity Our location in Sylmar, CA currently has an on-site opportunity for a Senior Regulatory Affairs Specialist.... Provides mentoring and leadership to Regulatory Specialist I and II team members Required Qualifications Bachelor's degree...
Job Title: Principal Professional, Regulatory Affairs – Labelling Job Location: United States Job Location... coordinators, Internal Graphics Design Team, Regulatory Affairs, Quality, Marketing, Product Development and internal and external...
Florham Park, USA Posting date: 22 Jan 2025 Reference: 63923 Associate Director/Director, Regulatory Affairs - Permanent... and ICH guidelines. The Associate Director/Director, Regulatory Affairs' responsibilities will be: Develop and execute regional...
New Jersey, USA Posting date: 20 Jan 2025 Reference: 63719 Senior Manager, Regulatory Affairs - Permanent - New... are a plus. Experience in regulatory affairs within the pharmaceutical or biotech industry, with a strong understanding of global...