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

Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. Lead cross functional groups across the organization in the development of global regulatory strategy to complete developmental and post approval regulatory submissions. Define contributions for submissions, communicate to functional con

The Associate Director, Global Regulatory Affairs Labeling, will be responsible for regulatory support in the area of product labeling. This position reports to the Director, Global Regulatory Affairs Labeling and will be responsible for creating, updating, and maintaining labeling documents throughout the product lifecycle, with primary focus on Company Core Data Sheets

Manage regulatory team members by communicating clear priorities and focused objectives in line with short and long term business plans. Drive the development and execution of regulatory strategies and tactical plans for registration of products in the US and Canada. Lead the preparation, submission, and approval of quality US EPA submissions. Ensure compliance with all a

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state of the art biotechnologies to discover and deliver novel medicines in four disease areas bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments c

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

/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

Duties WHAT IS THE APPEALS DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Independent Office of Appeals Specialized Exam Programs & Referrals/Area 10/Team 2 The following are the duties of this position at the full working level. Conducts Appeals conferences for the settlement of the largest and most

Site Name USA Maryland Rockville, USA Pennsylvania Upper Providence Posted Date Apr 11 2024 Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a

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

As the Director of Regulatory Affairs, you will lead a talented team and drive regulatory strategies for our groundbreaking products, focusing on New Drug Applications (NDAs) and Biologic License Applications (BLAs). You will spearhead the preparation and submission of regulatory documents, ensuring compliance with stringent FDA regulations and facilitating productive eng

Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL (LBI) DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Large Business and International Director Northeastern Compliance Practice Area (NECPA) The following are the duties of this position at the full working level. If this vacancy includes more than

Who we are LANXESS is a leading specialty chemicals company with sales of EUR 7.6 billion in 2021 and more than 13,000 employees in 33 countries. The core business of LANXESS is the development, manufacturing and marketing of chemical intermediates, additives, specialty chemicals and plastics. LANXESS is listed in the leading sustainability indices Dow Jones Sustainabilit

Lead Chatham's US Regulatory and Documentation practice, a unified team supporting all of our client sectors in navigating applicable regulations Collaborate with the International Regulatory and Documentation practice lead to ensure an appropriate degree of alignment in processes, priorities, and talent development Partner effectively with stakeholders outside of direct