A company is looking for an Associate Director, Global Regulatory Project Management and Strategic Planning - GI. ...
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...
A company is looking for a Regulatory Consulting Associate responsible for preparing plan documents and providing regulatory compliance support. ...
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 ...
A company is looking for a Senior Associate, Regulatory Operations. ...
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...
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 ...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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 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...
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 ...