The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. The Associate, Regulatory Labeling reports into the...
Perform other regulatory tasks as assigned. Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies. ...
Perform other regulatory tasks as assigned. Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies. ...
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...
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...
On-Board Scientific is hiring a Regulatory Affairs Assistant!. The Regulatory Assistant needs to exhibit working knowledge of pharmaceutical operations. The Regulatory Assistant will need to utilize scientific and technical information to ensure that documents produced are consistently accurate and ...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. Those aren’t words that are u...
Essential Functions Serve as a member of the Global Project Team (GPT) utilizing precedent and experience to develop innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed ...
The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. The Associate, Regulatory Labeling reports into the...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. Leadership responsibility for...
Lead the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality regulatory deliverables to the GPTs. Present regulatory strategies including communication of regulatory risks and associated mitigation plans to ...
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 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...
Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals. ...
Director/Associate Director, Global Regulatory Affairs - CMC. The project portfolio at Genmab is evolving, and we are therefore looking for a Director/Associate Director to join the Regulatory Affairs CMC team. You will report to the Senior Director of Regulatory Affairs CMC and be part of the Regul...
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, ...
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...
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...
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 & backgrou...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. Leadership responsibility for...
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...
Join our dynamic and expanding mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations where you will utilize your knowledge and experience to build a stronger Regulatory Operations team by providing guidance, as well as regulatory system and process support for th...
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...