The Associate Director, Regulatory Operations – Dossier Planning is responsible for the management and oversight of the US Dossier Planning team. The Associate Director provides leadership and oversight to create submission plans that result in high quality regulatory submissions and procedures incl...
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 individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
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...
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...
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...
Manage, direct, and drive the strategy for all Regulatory activities associated with the registration and support of new and approved drug products. Be accountable to the Global Head of RA, and Global Regulatory Strategy Committee (G-RSC) for the development of global regulatory strategies. Job Titl...
Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, and competitor analyses) for Target Product Labeling, CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentraliz...
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. ...
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...
The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Regulatory Affairs (RA) Associate Director, L...
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...
CRM performs work on a variety of regulatory compliance related matters. The CRM team is an oversight control function within BX Central Legal & Compliance designed to assess the effectiveness of BX’ policies and procedures, particularly with respect to regulatory compliance of the BX registered...
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...
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. Implements regulatory strategies and solutions to assure all adverti...
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...
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...
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...
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...
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...
This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position drives/leads the maintenance of global labeling and associated d...
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 ...
The Associate Director, Regulatory Operations – Dossier Planning is responsible for the management and oversight of the US Dossier Planning team. The Associate Director provides leadership and oversight to create submission plans that result in high quality regulatory submissions and procedures incl...
Senior Associate, Regulatory Affairs. They’re looking for skilled regulatory professionals like you to help complete meaningful and impactful projects. Prepare regulatory submissions, including Original ANDAs, Amendments, Annual Reports, Supplements, and PADERs for applications. Review supporting su...