/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t

Braun Medical Inc. ("B.Braun") has an opening for a Senior Counsel, Life Science Regulatory and Quality. The Senior Counsel, Life Science Regulatory and Quality, will support a wide variety of global regulatory and quality matters related to the design, manufacture, distribution and sale of medical devices and pharmaceuticals throughout the world, including product submis

A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner

SHIFT Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a

Senior Regulatory Affairs Associate Experience Biologic CMC 5+ years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to new application, post approval variations Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appr

Local submission of CTA according to the EU directive until the end of the transition period in Belgium, France, Luxembourg and Monaco, then submission according to EU CTR Local submission of MAP and NIS Education Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred Language skills Must be fluent in French and Englishcommunicat

t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organization where people can

We are looking for a Senior Regulator y Affairs Associate to join our growing team in Romania. This role can be either home or office based in Bucharest. As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail Applications (CTA) from various European locati

Under the general direction of the Director of Regulatory Affairs, executes the hospitalrsquo;s regulatory readiness processes to assure compliance with regulations and standards of regulatory and accreditation agencies. Assesses and determines survey readiness and compliance to all accrediting and licensing agencies by identifying areas of noncompliance and works with le