Certis Biologicals is currently seeking a highly motivated individual to join the Regulatory Affairs team as a Federal Regulatory Affairs Manager. The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all C...
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 ...
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...
The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position involves interpreting ...
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 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 ...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. ...
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...
Gathers information through research, statistical reports, and interviews with technical staff and maintains consistent communication with technical team leads. Writes, formats, and edits contract deliverables and technical documents in support of the Peraton Program Management Office (PMO) and serv...
Former experience in leading or guiding more junior technical writers. Writes and updates material for reports, manuals, briefs, proposals, instruction books, catalogs, and related technical and administrative publications concerned with work methods and procedures, and installation, operation, and ...
AlliedTravelCareers is working with CompHealth to find a qualified Pharmacist in Salisbury, Maryland, 21801!. Our pharmacy department is looking for an experienced clinical oncology pharmacist specialist to join our team in a full time capacity serving primarily in our state-of-the-art Cancer Center...
Three (3) years of experience in conducting quality assurance (form, content, grammar and requirement compliance) of systems and software processes, PCA, documentation, and verification audits required. ...
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
Global Trade Compliance Specialist. Global Trade Compliance Specialist. This position focuses on implementing international trade compliance activities into daily business operations, conducting compliance assessments, and working with a variety of internal stakeholders to ensure that the proper pro...
Desired: Previous pharmacist experience in a high volume retail setting. ...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
As a Staff Pharmacist, you have a critical role at the forefront of delivering our purpose, modeling our values, and demonstrating genuine, authentic care for our patients. A key component of the Staff Pharmacist role is keeping your customers and patients healthy through adoption and management of ...
As a Staff Pharmacist, you have a critical role at the forefront of delivering our purpose, modeling our values, and demonstrating genuine, authentic care for our patients. Workflow Management A key component of the Staff Pharmacist role is keeping your customers and patients healthy through adoptio...
Currently, ManTech is seeking a motivated, career and customer-oriented Quality Assurance Specialist to join our team in the Columbia and Hanover, MD area. Three (3) years of experience in conducting quality assurance (form, content, grammar and requirement compliance) of systems and software proces...
Requirements**Licensure / Certification / Registration:+ Pharmacist credentialed from the Maryland Board of Pharmacy obtained prior to hire date or job transfer date required. ...
Three (3) years of experience in conducting quality assurance (form, content, grammar and requirement compliance) of systems and software processes, PCA, documentation, and verification audits required. ...
Fairly and consistently reviews team interactions with both internal and external parti Quality Assurance, Assurance, Specialist, Customer Service, Remote, Healthcare, Business Services. The Quality Assurance Specialist I is responsible for examining and evaluating the accuracy of transactions in ac...
Identifies issues to be pursued based on large, unusual or questionable items that produce a significant tax or compliance effect and utilizes the tax law and facts needed to resolve them. ...
International Events Manager - Program Specialist. This Program Specialist will provide key support to the Institute's Director and Senior Program Officer II and the other members of the Anchor team who ensure that the Institute's overall strategic goals are met. Establish processes and track progre...
Large Business and International, Director, Withholding, Exchange and International Individual Compliance (WEIIC), DFO IIC. Identify issues to be pursued based on large, unusual or questionable items that produce a significant tax or compliance effect and utilizes the tax law and facts needed to res...