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...
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, re...
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 & Regulato...
Do you have experience in all aspects of a Regulatory Affairs project, supporting technical/ CMC, clinical, nonclinical and procedural aspects of strategy and submissions, but are looking to take this to the next level, supporting a best in class vaccine as we expand into new markets and maintain cu...
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...
Manager, Regulatory Affairs Advertising & Promotion - Remote. Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment update...
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...
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, re...
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...
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...
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...
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...
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...
Manager, Regulatory Affairs Advertising & Promotion - Remote Location: Gaithersburg, MD, US, 20879We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Regulatory Affairs, Advertising and Pro...
The Compliance Analyst role within the Housing Opportunities Commission of Montgomery County entails a comprehensive set of responsibilities critical to maintaining and enhancing the quality and compliance of our affordable housing operations. The Compliance Analyst is responsible for identifying an...
As a Senior Project Manager in the IT PMO at DFIN, you can achieve results you never thought possible by leading critical and strategic IT projects. This position will lead, and direct multiple projects engaged in the design, implementation, and modification of IT projects (IT Infrastructure/ Securi...
If so, we 're looking for someone like you to join our team! We are seeking a Compartment Security Compliance Project Analyst (CSCPA) to help provide APL and its sponsors with the highest level of security support. Compartment Security Compliance Project Analyst (CSCPA). Provide security guidance re...
As a Cybersecurity Compliance Manager. You will support the Chief Information Security Officer (CISO), the Chief of Classified IT Compliance and the Principal Organizational Information System Security Manager (ISSM) in carrying out the Laboratory 's Classified Information Security Program. You will...
Coordinate and prepare regulatory submissions in collaboration with regulatory lead(s). Supports regulatory departmental activities as needed, including the authoring and reviewing of regulatory SOPs, work instructions, and templates. Stay abreast of regulatory guidance and changes in regulatory cli...
Does the changing of the seasons have you wishing for a life-changing career move? An employee benefits compliance analyst role is available!. Develop compliance materials, including whitepapers and presentations. Monitor, summarize, and communicate legislative updates and compliance requirements to...
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 Lead Case Manager is responsible for coordinating case management and safe and timely release services, training new case managers, and supervising the work of other case managers. Proficient use of desktop and laptop computers, internet search, people management programs, smart phones and table...
Project Manager/ Agile Scrum Master - Federal SectorManhattan StrategyGroup (MSG) in Bethesda, MD is seeking a Project Manager/Agile Scrum Master (PMP) to support a Federal contract for the Department of Labor (DOL), Office of Chief Information Office (OCIO). Creates, manages, and tracks project doc...
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...