The Director of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards. Responsible for all quality assurance and regulatory functions across POC's Portland & Gardner site...
My client seeks a highly motivated Director of Regulatory Affairs to join their growing organization. In this role, you will be responsible for all activities to lead and maintain global regulatory approvals to market devices throughout the product development lifecycle while building and managing a...
The Regulatory Affairs CMC Officer for Cytiva is responsible for leading CMC strategies for internal and partner programs. Proactively identifies CMC/cGMP issues and implements appropriate regulatory strategies to mitigate CMC dossier, QP, import/export, and other biomanufacturing regulatory documen...
Compile necessary information and prepare Regulatory license applications that meet specific country requirements to support international markets, as well as internal regulatory file documentation. May act as a core team member on development teams, providing Regulatory Affairs feedback and guidanc...
Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory agencies, CROs, consulting groups, and other third parties. Significant regulatory affairs experience is required. Provides stra...
As a part of the Rhythm Management division, the Regulatory Affairs Specialist works to deliver advanced, life-saving and sustaining technologies to patients worldwide. Under direct supervision, the incumbent will help plan, implement, and manage regulatory submissions to the US FDA and EU notified ...
Leads the Regulatory Affairs team to design and execute regulatory strategy for approval and commercialization of the company’s products, including preparation, review, and submission of appropriate background documents and regulatory submissions. Keeps executive leadership team informed of regulato...
Reporting to the Vice President of Global Regulatory Affairs (GRA), the Director of Chemical and Biological Regulatory Affairs will be responsible for setting the strategy for and leading the Chemical/Biological Regulatory Affairs team within the Global Regulatory Affairs organization. Assists in th...
Must have previous experience in conducting all regulatory affairs activities including meeting submissions, IND, and clinical trial applications and regulatory filings. Requires experience in the management of regulatory documentation and compliance, and in the management of a regulatory functional...
Reporting to the Director for the Global Regulatory Affairs Operations team, this role represents the Regulatory Affairs users, collaborating with the Magellan Workstreams, Master Data Team, Site Leads and other Stakeholders across the network. As the Regulatory Affairs Functional Lead, you will pla...
As a part of the Rhythm Management division, the Regulatory Affairs Specialist works to deliver advanced, life-saving and sustaining technologies to patients worldwide. Under direct supervision, the incumbent will help plan, implement, and manage regulatory submissions to the US FDA and EU notified ...
This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...
Reporting to the Director for the Global Regulatory Affairs Operations team, this role represents the Regulatory Affairs users, collaborating with the Magellan Workstreams, Master Data Team, Site Leads and other Stakeholders across the network. As the Regulatory Affairs Functional Lead, you will pla...
The In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory Strategy Group (GRS) collaborate with the Precision Medicine and Clinical Sciences Teams to help develop and execute biomarker strategies across its growing clinical portfolio. Manager, Regu...
Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage client relationships. Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on reg...
Soliant is seeking several experienced Inpatient Pharmacists to assist with the current COVID-19 situation. ...
The Pharmacist is responsible for maintaining standards of professional and ethical practice in the provision of. PHARMACIST MINIMUM REQUIREMENTS. PHARMACIST ESSENTIAL FUNCTIONS. ...
Under the general direction of the Associate Director or designee, the Consultant Pharmacist Team Lead functions as a team leader/member of the drug utilization review and medication management therapy programs within Clinical Pharmacy Services (CPS). This position will participate in, and may overs...
Under the direction of the Program Coordinator, the position will work collaboratively with the Youth Worker Coaches to ensure the Recreation Worcester Program staff have a positive working and learning experience at the summer program sites. CASE MANAGER, RECREATION PROGRAM. Case Manager, Recreati...
The Consultant Pharmacist II serves as a resource for Consultant Pharmacist I staff. Manager or Consultant Pharmacist Team Lead or designee. Consultant Pharmacist II functions as a team member of the drug utilization review programs within Clinical Pharmacy Services (CPS). This position handles live...
The Clinical Care Manager (CCM) provides, coordinates, and organizes evidence-based care management to our Medical Assistant Treatment Program (MAT) patients. We are currently hiring a RN Clinical Care Manager based in Worcester MA. Responsible for assisting Primary Care Providers (PCPs) in coordina...
The Director of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards. Responsible for all quality assurance and regulatory functions across POC's Portland & Gardner site...
Kirby Bates Associates, a national healthcare leadership firm, has an engagement opportunity for an Interim Manager/ Documentation Regulatory Specialist in Massachusetts at a residential and LTC facility. The leader must be able assist at the unit levels with hands-on monitoring and mentoring and ha...
The Program Manager manages a variety of projects and programs which require coordination across a wide range of functional groups. ...
Responsible for QA oversight of the development and implementation of Quality, manufacturing, and laboratory systems/processes to facilitate new projects and continuous improvement activities. Provide support for GxP regulatory inspections, as needed, including acting as subject matter expert for Qu...