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...
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 mat...
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...
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...
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...
Working with Global Regulatory Policy and other stakeholders to advocate for therapeutic areas/local positions on regulatory issues and shape the regulatory environment on selected issues through liaising with trade associations. Associate Director, Regulatory Affairs UK. A new opportunity has arise...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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, ...
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 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...
Canada Chemical regulatory oversight and review. Bachelor's degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs. ...
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...
Regulatory Affairs Associate located in Clark, NJ. It is not a lab-based role, but rather a corporate 'desk job' supporting regulatory registration for global product launches. ...
Associate Director, US Regulatory Affairs, Advertising & Promotion - Permanent - NJ & MA. Proclinical is seeking an Associate Director, Regulatory Affairs, Advertising & Promotion for a global pharmaceutical company with their location in New Jersey. The Associate Director, Regulatory Affairs, Adver...
HM is looking for someone that has Canada and US artwork review experience, as well as notifying cosmetics in Canada - and a plus would be if they know how to assess the chemical regulatory aspects in Canada. Canada Chemical regulatory oversight and review. Position requires a Bachelor's degree in a...
The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group. Ability to interpret Regulat...
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 %: ...