As an Associate Director of Regulatory Affairs, you will represent regulatory affairs on cross-functional teams and provide regulatory advice on clinical development matters. Associate Director, Regulatory Affairs. Regulatory Affairs, regulatory submissions, drug development, oncology, FDA, EMA. The...
This Associate Director of Regulatory CMC will directly report to the Senior Director of Regulatory Affairs, CMC, and will be responsible for representing regulatory CMC on cell therapy pipeline + products. Associate Director, Regulatory Affairs CMC. Regulatory Affairs CMC experience in a pharma/bio...
As a Senior Associate of Regulatory Affairs, you will support Regulatory Affairs management in the day-to-day operational aspect of the department and support interactions with global regulatory authorities. Senior Associate, Regulatory Affairs. Represent Regulatory Affairs on project teams and clos...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
Associate Director Regulatory Affairs (Temp to Perm). Oversee regulatory submissions and approvals, ensuring alignment with global regulatory standards. Lead regulatory strategy development and execution for both U. Collaborate with stakeholders to establish project timelines and regulatory goals. ...
Were seeking a skilled Cybersecurity Compliance Analyst to join our client in a remote capacity. The ideal candidate will have a strong background in compliance programs cybersecurity and clientfacing roles within a Managed Service Provider (MSP) environment. Manage compliance programs with a focus ...
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
Seeking experienced Project Managers to lead the delivery of complex projects within the healthcare industry, managing multiple work streams across different regions. Primary Skills: Project Management-Expert, Healthcare Product-Advanced, Cost Benefit Analysis-Expert, Business Presentation-Expe...
We are looking to add an experienced and eager Civil Engineer/Project Manager to our Land Development Team based out of Sacramento, CA. Design and draft land development concept plans for a variety of projects including commercial, residential, and industrial projects. Successful candidates will be ...
Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, CMC Regulatory Affairs, Biologics. ...
As a Project Manager, you will be overseeing the overall direction, coordination, implementation, execution, control and completion of specific AV systems integration projects. In addition, the Project Manager will ensure projects achieve time, scope, budget, quality, safety and customer satisfactio...
Our partner, a leader in innovative biopharma resources and patented ingredients, is seeking a Regulatory Affairs Specialist to join their Los Angeles team. This role offers a chance to contribute to groundbreaking developments and regulatory processes with a global impact. Develop and support regul...
Full Time – Grant Compliance Specialist I (GCS I). This role involves assisting in compliance monitoring and reporting, with supervision. Assist in the development of program policies, procedures, and compliance monitoring strategies, with supervision. Provide support on federal regulations, eligibi...
This Senior Director/Director of Regulatory Affairs will also oversee the preparation of all regulatory documents and submissions, mentor junior team members, and stay updated on changes in FDA and EU regulations. Senior Director/Director of Regulatory Affairs. Regulatory Affairs experience in a pha...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. ...
The Senior Regulatory Affairs Specialist plays a vital role in ensuring compliance with global regulatory standards for medical devices. The ideal candidate will possess strong regulatory expertise, with a focus on technical documentation and regulatory compliance. Minimum of 5 years’ experience in ...
Liaise with colleagues in Regulatory Affairs therapeutics teams, company local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, Regulatory Affairs III. Sen...
Senior Regulatory Affairs Specialist. Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings. Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions. Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK ...
Produce regular reports necessary for Project compliance for IRA and DOL Compliance. Quickly respond to and resolve any non-conformities identified within the project site based on guidance from Compliance Specialist. Monitor apprenticeship program metrics for a project site to ensure 100% complianc...
The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. Regulatory Compliance - knowledge of federal and municipal regulatio...
As a member of PointClickCare’s Legal and Compliance team, In the role of Compliance Analyst, you will be instrumental in driving key initiatives and projects that have a substantial impact on PointClickCare, its customers, and other stakeholders. Assist in the development of, and ongoing updates to...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
We currently have an opportunity in California for a Senior Water Resources Project Manager with interest and experience in the areas of hydrology, supply, and demand forecasting and management, supply vulnerability and risk analyses, water systems modeling, integrated planning, and decision support...
Splunk is looking for a motivated Senior Analyst who is passionate about delivering technology assurance, advisory, compliance and risk management services to the company. You will ensure proper identification and mitigation of risks / processes / internal control gaps that have potential operationa...
PearlX is seeking a Project Finance Manager to be a leading contributor to our finance department in project diligence, asset underwriting, and project financing. Lead financial modeling efforts for project cashflows, accounting, and valuation outputs across individual projects and multi-site portfo...