Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. Provide oversight of regulatory submission...
The Associate Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently managing life cycle plans along with regulatory submissions and approvals. Associate Director – Regulatory Affairs. Establish regulatory st...
The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products. Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development...
Consumer Products Litigation & Regulatory Associate. The associate hired for this position will focus primarily on regulatory matters, including those involving the CPSC, FTC, and NAD. Affirmative regulatory reporting and responding to regulatory investigations. Dentons’ Consumer Products team h...
The Associate Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently managing life cycle plans along with regulatory submissions and approvals. Comprehensive knowledge of current US and ex-US regulations and ...
At least 8+ years of regulatory affairs experience for the associate director or 10+ years of regulatory affairs experience for the director in the pharmaceutical or biotechnology industry. Lead to deliver high quality and timely regulatory submissions in alignment with corporate goals, and in compl...
Develop, implement, and update procedural and training manuals for the Regulatory Associates and Regulatory Department. Work closely and collaboratively with clinical project management staff to plan and delegate collaborative tasks for study coordinators and regulatory associates to ensure completi...
The Associate Director of Regulatory Affairs will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and De Novo submissions. Job Title: Associate Director of Regulatory Affairs. Conduct regulatory assessments for product change...
Associate) Director, Regulatory Affairs – Permanent – San Francisco Bay Area. Proclinical is seeking an (Associate) Director, Regulatory Affairs for a clinical-stage biopharmaceutical company located in the San Francisco Bay Area. A degree in a life science, chemistry, or chemical engineering or clo...
The Regulatory Associate will primarily focus on provider reimbursement issues, Medicare and Medicaid appeals, and audits and internal investigations, supporting the firm's robust and sophisticated regulatory and reimbursement practices. A leading national healthcare law firm is seeking a Regulatory...
The Associate Director of Regulatory Affairs will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and De Novo submissions. Job Title: Associate Director of Regulatory Affairs. Conduct regulatory assessments for product change...
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. ...
We are supporting a small growing biotech in the Bay Area looking for a Senior Regulatory Affairs Associate!. Atleast 2 years experience in a regulatory setting at a biotech company. Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory ma...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips' Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
Global Trade Compliance Specialist role is vital to ensure that the requirements (relevant laws and regulations) and business processes associated with the cross-border movements, run efficiently while ensuring that any risks are identified and managed optimally. Global Trade Compliance Specialist a...
You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products. You have experience with US regulatory affairs submissions such as 510(k) and/or PMA. Have previous experience with various regulatory affairs submissions. You understand how to take t...
The Ambulatory Regulatory Compliance Specialist has a pivotal role within the organization and is responsible for ensuring adherence to regulatory standards across diverse areas. The Ambulatory Regulatory Compliance Specialist will play a crucial role in ensuring ongoing compliance with The Joint Co...
The base range for a Director, Regulatory Affairs is $212,000 - $245,000 and Senior Director, Regulatory Affairs is $260,000 - $295,000 per year. Director/Senior Director, Regulatory Affairs Advertising and Promotion. The Director/Senior Director, Regulatory Affairs Advertising and Promotion will pl...
Southern California Water/Wastewater Market Project Manager. This is anticipated to include identification of key clients, development and management of strategic relationships, development, and management of the regional project pipeline, represent the firm in the various professional organizations...
You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products. You have experience in the past with US regulatory affairs submissions such as 510(k) and/or PMA. Have previous experience with various regulatory affairs submissions. You understand h...
Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings. Responsible for the development of the CMC regulatory strategy for submissions, including IND/CTA/BLA, NDA, CTD, and MAA regulatory filings. Represent Regulatory CMC on cross-functional teams such as GPDO d...
Represents the Regulatory Affairs department as a member of project teams, certain boards, and as part of other meetings as the need arises. Providing regulatory affairs support for all aspects of product development and manufacturing. Evaluating proposed engineering, manufacturing, labeling and qua...
Prepare the team for and participate in regulatory inspections or other official engagements related to Cibus Regulatory Compliance Program, demonstrating Cibus compliance with regulatory requirements and Cibus internal standards. Regulatory Compliance Specialist. Cibus has an immediate opening for ...
The Senior Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance. Senior Regulatory Affairs Specialist. In this pivotal role, you will leverage your expertise to navigate complex regulatory landscapes, ensuring our groundbreaking ...
Position: Project Manager - Land Development. This employee owned national firm is seeking a civil project manager with an interest in residential and other site civil design (healthcare, military, hospitality, education, recreation). Develop project proposals, scopes, and budgets, and manage execut...