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 labeling, commensurate with the available data. Accountable to GRL and Global...
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...
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 ...
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...
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 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...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
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 ...
Manager, Regulatory Affairs Advertising & Promotion - Remote. 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, nu...
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...
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 ...
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 ...
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 ...
Regulatory Affairs Manager - (MGRRA_COMPANY_1). Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), and to ensure com...
As the Deputy Super Office Director for Operations, the incumbent will oversee offices within OND that manage the regulatory, business process, and administrative operations, providing leadership and supervision on developing and implementing relevant processes and procedures, and assuring that key ...
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...
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...
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...
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 ...
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...
The Senior Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects. Management of facilities and equipment matters required for INDs, registration a...
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...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
This is the second Regulatory Affairs level in the series. The Regulatory Compliance Specialist is a critical member of the Regulatory and Laboratory Compliance team of Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sc...
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. Director Regulatory Affairs - Late Cardiovascular, Renal and Metabolism...