The Senior Manager, Public Policy in International Government and Regulatory Affairs (IGRA) is an integral position within a global team of public policy and regulatory affairs experts. Play an active role in supporting the execution of key projects within the International Government & Regulatory A...
Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred. Regulatory Affairs, Adve...
As a Senior Regulatory Affairs and/or Quality Affairs Consultant you work closely with our Head of Regulatory to support medical device (MD), in-vitro diagnostic medical devices (IVD) with a focus on software as medical device (SaMD), including AI as a medical device (AIaMD), companies to bring thei...
Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. What do we expect from you as a Consultant Regulatory Affairs IVD?. EU and preferably also in non-EU Quality Systems & Regulatory Affairs consulting for In Vitro Diagnostics (I...
Demonstrated ability to drive high-level regulatory strategy and navigate complex regulatory landscapes. The client is seeking a highly experienced professional to lead their regulatory strategy for a late-phase oncology program. Spearhead regulatory submissions for the oncology portfolio, driving s...
Collaborate with cross-functional teams to develop and implement regulatory strategies, manage regulatory risks, and ensure compliance with current regulations for cell therapy products. Prepare and manage regulatory submissions (INDs, CTAs, BLAs/MAAs) to agencies like the FDA and EMA. Ensure qualit...
Support the lead regulatory strategy for late-phase oncology programs, ensuring alignment with global regulatory requirements. Minimum of 8 years of industry experience, with at least 4 years in regulatory affairs. Strong technical proficiency in regulatory affairs is crucial. The client is seeking ...
Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred. Regulatory Affairs, Advertis...
Develop and implement regulatory labelling strategies for new product labels and launches. Contribute to or lead strategic initiatives, ensuring compliance and alignment with global regulatory requirements. Associate Director Level: Minimum of 7 years in the pharmaceutical industry, with at least 4 ...
The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position involves interpreting ...
The Executive Director oversees all aspects of the agency’s operations, including licensure, survey, and certification activities; administration; fiscal services; human resources; information technology; quality improvement; government and regulatory affairs; emergency preparedness; quality initiat...
Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred. Regulatory Affairs, Advertis...
The Senior Regulatory Affairs Director (RAD), Global Regulatory Strategy. To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of. Regulatory Affairs Strategists. You will work across disciplines in an atmosphere of collaborati...
Director, Global Regulatory Affairs, Development Strategy. Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i. Providing support to regulatory affairs reviewers...
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 Director, Regulat...
Reporting to the Vice President of Global Regulatory Affairs (GRA), the Director of Chemical and Biological Regulatory Affairs will be responsible for setting the strategy for and leading the Chemical/Biological Regulatory Affairs team within the Global Regulatory Affairs organization. Assists in th...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products. Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory aff...
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy. Accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory stra...
This position will receive continuous guidance and mentoring by the Director of Regulatory Affairs and/or the Deputy Chief Regulatory Officer and the Chief Regulatory Officer, as applicable. The Manager of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regula...
Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients.USP's fundamental belief that Equity = Excellence manifests in our c...
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company ...
Partners with and helps key stakeholders' teams to implement reporting and quality improvement projects in help of BSWH's strategy to deliver high-quality, safe care and achieve excellence in accordance with regulatory statues, policies and procedures. Helps and/or facilitates departmental processes...
Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (, commercial, research, clinical development, medical affairs, business development, legal, manufacturing, qual...
Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Director* Global Regulatory Affairs CMC Authoring. ...