Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lex...
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...
The Associate Director, Regulatory Advertising & Promotion will be tasked with leading, initiating, reviewing and approving strategies for non-promotional and promotional materials to comply with regulatory requirements worldwide throughout the product life cycle. Will coordinate regulatory trai...
Associate Director, Global Regulatory Affairs in Cambridge, MA with the following requirements:. Provide global regulatory oversight and execute regulatory activities on late-stage development in multiple indications, device platforms, and cell line changes. Master’s degree in Pharmacy, Biomedical E...
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 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 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...
The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in some cases a regional regulatory lead, for development and/or...
Role that serves as a Health Authority liaison and key member of project teams, establishes and communicates regulatory strategies for development programs and coordinates the timelines, generation, and submission of complex regulatory dossiers. Maintains knowledge of regulatory requirements and ant...
The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. Serve as a CMC strategist and project leader for projects/programs, providing r...
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 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...
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...
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...
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...
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...
Manatt, Phelps & Phillips, LLP, 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 o...
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...
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...
Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach using scientific rationale and in alignment with regulatory guidance, working in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program a...
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...
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 ...