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...
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 & Regulatory A...
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...
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...
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...
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 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...
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...
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...
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...
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...
The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). 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 w...
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...
We are seeking a Section 508 Compliance Analyst to provide support in managing, consulting and ensuring information and communication technology activities integrate appropriately with Section 508 compliance across the IT and acquisition lifecycles for the OCIO Customer Engagement Office in support ...
Prepares other Scientific and Regulatory documents for submission to Regulatory Authorities including pre-IND Meeting Requests and Packages, Orphan Drug Designation requests, Priority Review requests, Fast Track requests, etc. Experience in preparing regulatory documents, publishing regulatory submi...
Electrical Project Manager/Estimator Compensation & Benefits. Total compensation for the Electrical Project Manager/Estimator is between $80,000 and $125,000 depending on experience and maybe more than this range for candidates with exceptional experience and a successful history of performance....
Program Manager/Cyber Security Lead . Program Manager/Cyber Security Lead. The Program Manager/Cyber Security Lead will manage a large team providing cyber security risk assessment, policy, A&A lifecycle support, software assurance, incident response, and compliance validation. Se...
The Pharmacy Program Manager position is a 100% remote role requiring a HIPAA-compliant workspace. A Pharmacy Program Manager is a Clinical Pharmacist providing pharmacist support for an interdisciplinary care management team and members under assigned plan sponsors through conducting comprehensive ...
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...
As our EWOKS TO Deputy Program Manager, you will be providing programmatic leadership and management to our Team Leads who operate in Bethesda, MD; Reston, VA; Patrick Space Force Base, FL; and coordinate/collaborate with OSINT SMEs throughout the DoD and IC. The DIA/OSIC Program consists of four ma...
The compliance analyst will work alongside a dedicated team of highly trained compliance professionals to ensure our projects meet their compliance objectives. The Compliance Analyst serves as the project compliance expert on a wide portfolio of Clarks government-funded construction projects. This i...
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...