Prior experience must include: In the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead (GRL), on the global project team (GPT) for accountable individual projects; Provide global regulatory oversight and execute regulatory activities on late-sta...
Responsible for integrating and applying knowledge of global regulations governing radiopharmaceutical drug development supporting the Company's preclinical/clinical development/commercial programs, including, developing regulatory strategy for all phases of drug development in order to progress reg...
We have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. ...
The Regulatory Labeling Associate Director, Rest of World (ROW) is responsible for development and maintenance of product labelling for ROW markets across all therapeutic areas. This includes prescribing and patient information and associated business processes. Ensures compliance with labelling gov...
As an Associate within the Regulatory Reporting External Support team, you will be responsible for providing frontline support to the firm’s external shareholders for all matters related to regulatory reporting. As part of this role, you will also be responsible for partnering more broadly across th...
You will provide regulatory expertise for product development including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements and regulatory compliance. We are seeking an Associate Director/Director of Regulatory Affairs to join the company. Together with the dev...
The Associate Director, Regulatory Submission Management is responsible for the planning, managing and tracking of the regulatory portfolio of submissions across a number of assigned programs. The role will focus on achieving regulatory submission activities and driving the broader GRA team to ensur...
As an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Demonstrates acceptable skills with increasing independence ...
The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for leading and providing global CMC regulatory support for the clinical and commercial product portfolio. Partner with representatives of Regulatory Affairs including in-country ...
Track regulatory project status and informational documents. Interfacing with global regulatory partners and internal cross functional teams. Minimum of 3-6 years Regulatory Affairs experience required; biologics experience required. Clear understanding of content and organization of regulatory subm...
Independently directs as well as prepares global regulatory affairs strategies and executes regulatory activities for Syndax, with general guidance from manager and regulatory affairs leadership. Associate Director, Regulatory Affairs. Syndax has an exciting new opportunity for an Associate Director...
We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this role, you will play a vital part in supporting the development and submission of regulatory documents, ensuring compliance with all regulatory standards, and facilitating the approval process for clini...
Health Care Medicaid Regulatory and Policy Advising Associate Attorney. A law firm is seeking a Health Care Medicaid Regulatory and Policy Advising Associate Attorney for their Boston, MA office. The successful candidate will focus on regulatory analysis and policy advising related to the Medicaid p...
The Associate Director of CMC Regulatory Affairs will support post-approval CMC (Chemistry, Manufacturing, and Controls) changes, as well as global Supply Chain and GMP activities for Alkermes’ marketed products. Manage regulatory relationships with external CMOs and third-party packaging suppliers,...
If you are an independently motivated and results-oriented person who enjoys collaborative team-oriented environments where results are achieved through influence and the incorporation of multiple points of view, this is the role for you! As the Associate Director, Global Regulatory Strategy you wil...
Join Takeda as an Associate Director, Global Regulatory Lead, GI & Inflammation where you will define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Defines strategies and provides tactica...
Boston office of a BCG Attorney Search Top Ranked Law Firm seeks senior regulatory associate attorney with 8+ years of experience, including leading or acting as second chair in administrative, siting, and permitting proceedings before the NYS PSC, NYS Siting Board, NYS Office of Renewable Energy Si...
Prior experience must include: In the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead (GRL), on the global project team (GPT) for accountable individual projects; Provide global regulatory oversight and execute regulatory activities on late-sta...
Our firm is seeking a highly qualified associate with two to four years of health care regulatory experience to join our growing team. Our health care transactions and regulatory team assists with the structuring and negotiation of transactions, provides strategic advice on regulatory and compliance...
The Medical Writing Science Associate Director is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. Authors complex clinical regulatory documents (e. Participates in developing key messa...
We're working closely with the C-suite at an exciting medical-device company to recruit a Director of Regulatory Affairs & Quality Assurance, who will lead the development and execution of comprehensive regulatory and quality systems. Own the regulatory function, including managing a small regulator...
The Associate Director of Regulatory Affairs Strategy will be responsible for developing regulatory strategies to support clinical development plans, working cross-functionally across the organization. Associate Director, Regulatory Strategy. Associate Director of Regulatory Strategy. Ensure adheren...
Keeps abreast of regulatory compliance issues and assist in developing new Regulatory Department procedures, as needed. Prepare, assemble, review and/or evaluate, publish and archive new ANDA and life cycle management regulatory submissions in accordance with local regulatory requirements and guidel...
The Medical Writing Science Associate Director is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. Authors complex clinical regulatory documents (e. Participates in developing key messa...
The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. This goal must be achieved both as a component of an overall glo...