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...
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...
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 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...
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 ...
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...
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. ...
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...
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...
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...
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...
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...
The Director of Regulatory Affairs & Quality will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities. Leading Regulatory Affairs strategy end-to-end executio...
Director of Quality Assurance & Regulatory Affairs (QA/RA). The Director of Quality Assurance and Regulatory Affairs (QA/RA), will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. Minimum of 10 years of experience in quality assurance a...
American Specialty Health Incorporated is seeking a Specialist - HR Compliance to join our Human Resources (HRS) department. This position will oversee HR Compliance, lead HR audit efforts, oversee the Immigration Process and create and maintain standard operating procedures (SOPs). Researches, docu...
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...
Closely follow and communicate compliance and regulatory developments that affect mortgage lending compliance. Follow Document Compliance procedures to verify compliance with regulatory and internal requirements. Conduct research on federal, state, agency, and investor regulations and guidelines usi...
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...
Maravai LifeSciences is seeking a #MiracleMaker to join our Finance and Accounting team as a Senior SOX Compliance Analyst. As a Senior SOX Compliance Analyst, you will be responsible for assisting with risk assessments, control design, helping control owners anticipate testing and documentation req...
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...
The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulato...
Evaluating proposed engineering, manufacturing, labeling and quality system changes and performing global regulatory impact assessments for regulatory filings and approvals. Supports Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories. R...
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...