The Manager, Regulatory Affairs Operations is responsible for supporting the development of documents created for, and as a result of, worldwide regulatory submissions. The incumbent utilizes and supports systems and processes by which regulatory documentation (internally generated or received) is created, approved, submitted, and maintained for use and made readily searc

The Associate Director, Regulatory Affairs CMC will be responsible for leading global regulatory CMC strategy for product development and registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) according to global regulatory expectations and requirements. This position works cross functionally with Regulatory Af

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

/JOB PURPOSE Responsible for creating, updating, and maintaining product information and labeling documentation for all relevant Exelixis products across our product portfolio. This position plays an important role in company wide initiatives around end to end labeling and provides dedicated support on Regulatory related activities and deliverables. This role requires an e

Site Name USA Maryland Rockville, USA Pennsylvania Upper Providence Posted Date Apr 30 2024 Are you looking for a highly visible role where you can ensure the development and execution of appropriate strategies across all stages of the product life cycle consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP)? If so, this role could be an exciting op

The Corporate Product Safety and Regulatory Affairs team has an opening for a PS&RA Manager, responsible to support the High Performance Polymers (HPP) business unit. In conjunction with the HPP business for which this position is responsible, the PS&RA Manager manage activities to assure compliance with legal and corporate product safety and regulatory affairs requiremen

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

Grow the planning practice in the Northeast/New York metro region and mentor staff. Lead business development activities, including developing and networking with clients, preparing planning strategies for proposals and contracts, and supporting regional market leaders in the real estate, institutional, state and local government, transportation, and energy markets. Devel

Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas SBSE Small Business/Self Employed, SB/SE Deputy Commissioner Exam, Specialty Examination, Estate & Gift /Excise Tax Exam The following are the duties of this position at the full working level. If this vaca

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

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

/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 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