Five (5) years of global regulatory affairs experience within the pharmaceutical industry in the job offered, as a Regulatory Affairs Specialist, or in a related occupation. Associate Regulatory Affairs Director. Contribute to regulatory submission strategy, identifying submission risks and opportun...
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 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 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. Director and Senior Director level). ...
Director Regulatory Affairs - Late Cardiovascular, Renal and Metabolism. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs...
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...
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 (, commercial, research, clinical development, medica...
The Director of Regulatory Affairs-Oncology will be accountable to the GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. Experience of all phases of the drug development process in regulatory affairs, including for p...
The Associate Director of Rare Disease Strategy will report to the CDER Center Director, work directly with both the CDER Center Director and CBER Center Director, and will serve as a cross-cutting role across both Centers to facilitate development and implementation of the integrated model. Quality...
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...
Center Director, Center for Devices and Radiological Health. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective. Demonstrated knowledge and ...
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...
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 ...
Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy. Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy . Define the strategy for regulatory interactions, lead regulatory meetings with national authorities and sovra-national agencies (e. Define a...
Providing expertise as the Global Regulatory Lead to Product Development Teams and serving as the regulatory single point of contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Coordinating interactions with foreign agencies through Regulatory Aff...
We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the United States. Center Director, Center for Devices and Radiological He...
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...
Five (5) years of global regulatory affairs experience within the pharmaceutical industry in the job offered, as a Regulatory Affairs Specialist, or in a related occupation. Associate Regulatory Affairs Director. Contribute to regulatory submission strategy, identifying submission risks and opportun...
Regulatory Affairs Manager in the Gaithersburg, MD area. As a Regulatory Affairs Manager in Gaithersburg, MD, you'll play a pivotal role in channeling our Scientific capabilities to make a positive impact on changing patients' lives. The RAM contributes to regulatory submission strategy, ide...
We are seeking a Senior Level Regulatory and Legislative Specialist in Rockville, MD. The Senior Level Regulatory and Legislative Specialist will leverage extensive experience in developing and managing Federal programs related to the U. The specialist will play a pivotal role in creating and implem...
In collaboration with executive leadership, the Executive Director, Medical Affairs will define the Medical Affairs strategy, advance collaborations with key opinion leaders and lays out plans for scientific engagement with health care practitioners, research groups, payers, and patient advocacy gro...
The Project Manager position is a highly visible strategic position to ensure exceptional project management in delivery of network services to NIH. Manage project status using ServiceNow Project Portfolio Manager. Leidos Health Mission Solutions is seeking a Senior Project Manager,. Provide overall...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. 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, regula...
We are seeking a Director of Operations that will be responsible to oversee and develop management of all areas of Manufacturing, Quality, Shipping & Receiving and Maintenance for 2 facilities within an hour drive (Dunkirk & Denton, MD. ...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. 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, regula...