Key responsibilities are to build strong relationships with key stakeholders within Member Supervision's regulatory programs and other Regulatory Operations departments, as well as cross-functional partners enterprise-wide, including Finance, Technology, and People Solutions to support business stak...
The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Proficiency in all tasks outlined for Regulatory Associate. A Senior Associate is expected to have a strong understanding of ANDA requirements and demonstrate that knowledge th...
The Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The Associate Director, Re...
The Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The Associate Director, Re...
The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background p...
Associate Director, Global Regulatory Affairs Operations, Authoring Support page is loaded Associate Director, Global Regulatory Affairs Operations, Authoring Support Apply locations Princeton, NJ time type Full time posted on Posted 5 Days Ago job requisition id R10133At Genmab, we’re committed to ...
Associate Director, Global Regulatory Lead (Oncology/Hematology) page is loaded Associate Director, Global Regulatory Lead (Oncology/Hematology) Apply locations Princeton - NJ - US Madison - Giralda - NJ - US time type Full time posted on Posted 2 Days Ago job requisition id R1582195. Develop strate...
Associate Director, Regulatory Affairs (Advertising and Promotion). The Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. ...
Finance Regulatory Reporting, Senior Associate. Prepare and review the regulatory calculations and regulatory form for each client, working with the client to close any client queries for each filing cycle. Join us to work with the world's leading investment fund managers, assisting them with meetin...
Prepare and review the regulatory calculations and regulatory form for each client, working with the client to close any client queries for each filing cycle. Join us to work with the world’s leading investment fund managers, assisting them with meeting the regulatory reporting obligations set by Gl...
Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities . Those aren’t words that are usually associated with a job. Develop global and/or US regulatory strategy for Oncology products in development and through life cycle management, ...
Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent experience. Quality/Risk Management Worldwide Regulatory Affairs. Johnso...
Regulatory Affairs Labeling Associate Level – I is needed to support Client' business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices. Applying strategic thinking, pharmaceutical educational knowle...
The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations. Associate Director Regulatory Operations. The individual will survey e...
The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background p...
Responsibilities Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits ...
Seeking a highly energetic and motivated individual to bring Regulatory expertise to an International Cosmetics Regulatory and Safety group supporting R&D to deliver fast-paced Beauty Care products to the market. Regulatory approval of cosmetic formula and artwork. Regulatory approval of raw materia...
Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency...
Pharmaceutical company looking for an experienced Quality Assurance and Regulatory Affairs Associate. Under the supervision of the Head of QA/RA, the QA/RA Associate is responsible for assisting the team with the maintenance quality and regulatory policies and procedures that ensure quality complian...
Associate Director, Global Regulatory Affairs Operations, Authoring Support page is loaded Associate Director, Global Regulatory Affairs Operations, Authoring Support Apply locations Princeton, NJ time type Full time posted on Posted 5 Days Ago job requisition id R10133. The Team Lead for Authoring ...
Translates and communicates regulatory requirements and strategies, as they affect regulatory submissions, to more junior regulatory team members and to internal and external functional business units. The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Aff...
Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs. The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned p...
This role is the key in ensuring the accurate and the timely submission of all Guerbet regulatory documents, staying current on all US federal regulations to ensure compliance, develop training programs and/or communications documents to meet regulatory requirements, and ensure that regulatory proce...
INDs/CTAs/NDAs/MAAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents, etc)</li><li>Responsible for the development, implementation, and rollout of training to the organization on Regulatory Operations processes and sy...
In this role you’ll be working with cross-functional teams to assist with the coordination and completion of international regulatory documents. This role will give you an opportunity to gain industry regulatory experience while helping deliver new therapies to patients and their families. Train and...