Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

/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

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

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

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

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

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

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

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