A company is looking for a Senior Regulatory Affairs CMC Associate. ...
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...
A company is looking for an Associate, Regulatory Affairs to join their Compliance team. ...
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...
A company is looking for a Senior Associate Regulatory Affairs for a remote position. ...
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 RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labeling activities and processes for regulatory submissions and product maintenance. The Regulatory Affairs (RA) Associate Director, La...
Job Title: Global Regulatory Lead, Oncology, Global Regulatory Strategy & Policy (Associate Director). Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities. Develop global regulatory strategy for Oncology products in developmen...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
Senior Regulatory Associate - Hybrid, NJ (2-3 days a week). You will be expected to prepare high-quality ANDA submissions (including amendments, supplements, and Annual Reports) with the support and oversight of the Senior Manager/Associate Director of Regulatory Affairs. Maintain and update senior ...
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...
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...
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...
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, ...
Description Kenvue is currently recruiting for: Senior Associate, Regulatory Affairs, Dietary Supplements This position reports to the Director, Regulatory Affairs and is based in Skillman. Role reports to: Director, RA Dietary Supplements Location: Summit, NJ Travel %: ...
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...