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 Regulatory Affairs Specialist is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory aspec...
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 ...
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. ...
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 ...
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 ...
Savor the flavor of a unique opportunity within our client's Regulatory Affairs group! They are seeking an entry-level Regulatory Affairs Analyst. If you've got a zest for detail and a taste for advancing your career in regulatory affairs, apply now!. Experience in Regulatory Affairs or related func...
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...
Title: Food Regulatory Affairs Analyst Location: Baltimore, MD - Hybrid 2-3 days a week on-site Schedule: M-F 8am-5pm Type: 6-month contract extendable with a potential for hire Pay: $20-25 per hour Start date: Immediate Overview: Savor the flavor of a unique opportunity within our client's 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 ...
The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products. The Regulatory Affairs team is responsible for obtaining and maintaining regulatory approvals for Certis Biologicals li...
What You’ll get to Do:* * Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team and line management * Reviews status of projects and budgets; manages schedules and prepares status reports * Assesses project issues...
Responsible for successful delivery of a program to a customer; or manage performance of a task or project as part of a larger program under direction of another PM. Interpret and break down high level requirements to execute projects and tasks at a rapid pace. Comfortable with managing highly compl...
The Assistant Project Manager is responsible for assisting the Project Manager with planning, directing, and coordinating, daily construction management activities. Reviewing project budget and timeframe with the Project Manager, and ensuring a good understanding. Assist the Project Manager and Supe...
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...
Quality Assurance Specialist (IT). The Project Management Office (PMO) seeks a Quality Assurance Specialist to join our team. Relevant coursework in Software Development, Software Testing, Algorithms/Data Structures, and Quality Assurance. You will play a key role in designing, developing, and execu...
Join RPh on the Go for an exciting travel opportunity as an Emergency Room Pharmacist in Arizona. ...
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...
NPME is currently seeking a PRN Vaccinating Pharmacist to administer COVID-19 vaccines. The person in this role will work with a team of pharmacists and pharmacy technicians to conduct activities related to administering COVID-19 vaccines. Must be a Registered Pharmacist in the State of Maryland. Mu...
The Pharmacist will provide information and advice regarding drug interactions, side effects, dosage and proper medication storage to patients and medical staff. ...
Education and Experience: .Bachelor’s Degree Preferred.Preference for degree in computer science, information systems, data science, or software or computer engineering.Eight (8) years’ experience supporting SDLC environments using tools such as .Net Framework, Visual Studio, HTM...
Education and Experience: .Bachelor’s Degree Preferred.Preference for degree in computer science, information systems, data science, or software or computer engineering.Primary responsibilities .Conduct business analysis and identify business objectives and requirements.Elicit,...