Regulatory Affairs Specialist: salario promedio en Silver Spring, MD in 2024

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. Interact with colleagues in other departments, R&D functions and ...

Ensures that protocol and regulatory documents are maintained and are kept up to date. Maintains study compliance with established local, state, federal, and DoD regulations for human subjects' research with institutional regulatory direction from USUHS, WRNMMC, and HJF. Maintains complete and accur...

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. Interact with colleagues in other departments, R&D functions ...

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 Sciences, Bethesda, MD. The Regulatory Compliance Specialist ...

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...

RESUME TO CRISS BRIENT at: Development:Leads development and implementation of projects, ser. ...

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...

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...

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 ...

Under general supervision from a Compliance Director, the Compliance Specialist monitors CNHS's adherence to regulatory requirements and organizational policies and procedures. Experience in a healthcare compliance role or equivalent experience (Required). ...

Regulatory Compliance Specialist - Clinical Trials. Leads the review of protocols, regulatory documentation, and other research activities to ensure compliance with relevant federal and local regulations and policies regarding research involving human subjects, laboratory animals, select agents, the...

The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products. The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vi...

The Office of Marketing Communications is seeking a high-energy, good-natured, highly collaborative, detail-obsessed administrative professional to join the team as Office Manager. The Office Manager will manage invoices and billing for advertising and marketing activities, manage data collection an...

The Analyst will play a pivotal role ensuring compliance with federal funding while supporting various components of the Compliance team. Climate United Fund, a 501(c)(3) nonprofit (“Climate United”), is seeking a full-time Compliance Analyst for an entry level position to support adherence to regul...

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...

Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine. Director, Global Regulatory Affairs – RNA vaccines. Are you interested in a highly-visible Global regulatory affairs role that allows you to drive strategy and shape...

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...

You will work closely with the Government Program Manager and Technical Points of Contacts to help execute their program within the defined schedule and budget, work daily with customers to provide status, and insight into program execution. Successful completion of at least one (1) year as Task Ord...

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...

Associate Director, Regulatory Affairs CMC Associate Director, Regulatory Affairs CMC. ...

Westat is seeking a Legal Compliance Specialist to join its legal team. In particular, this position supports and works closely with our in-house counsel in providing day-to-day consultation on legal compliance issues, including but not limited to employment, benefits, contracts, intellectual proper...

Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine. Director, Global Regulatory Affairs – RNA vaccines. Are you interested in a highly-visible Global regulatory affairs role that allows you to drive strategy and shape...

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...