A company is looking for a Director, Regulatory Affairs.Key Responsibilities : Focus on clinical regulatory filings and providing strategic and operational leadership on project teamsContribute to IND / CTA and BLA submissions activities for products in developmentDevelop regulatory strategies for assigned programs and communicate with regulatory agenciesRequired Qualifications : 10 years of pharmaceutical industry experience, with at least 5 years in regulatory affairsM.
D., Ph.D., or Pharm. D. degree or equivalent work experienceStrong background in Regulatory Affairs with successful interactions with Regulatory AgenciesKnowledge of global regulations, particularly US FDA regulationsExperience in managing regulatory activities associated with drug development programs
Director Regulatory Affairs
Key Responsibilities:Focus on clinical regulatory filings and providing strategic and operational leadership on project teamsContribute to IND/CTA and BLA submissions activities for products in developmentDevelop regulatory strategies for assigned programs and communicate with regulatory agenciesReq...
Regulatory Affairs Director - Global Regulatory Leader
A company is looking for a Regulatory Affairs Director - Global Regulatory Leader in General Medicine/Cardiovascular. ...
Compliance Specialist II
The responsibilities of the Compliance Specialist are to effectively develop, coordinate, and communicate commercial insurance product filings; perform regulatory research; and provide additional support and other regulatory functions as directed. Candidate will have expertise with ISO, NCCI, SERFF,...
Sr Manager Regulatory Affairs
A company is looking for a Senior Manager, Regulatory Affairs. Key Responsibilities:Lead creation and maintenance of Company Core Data Sheets (CCDS) activitiesDrive global implementation of CCDS into country-specific labelingFormulate and drive global technology initiatives for labeling and content ...
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As an Environmental/Stormwater Compliance Specialist, you will play a key role in supporting our commitment to environmental stewardship and regulatory compliance. Monitor and report on compliance with permit requirements, and assist in the development of strategies to address any non-compliance iss...
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The system wide Program Manager is an expert nurse who utilizes a collaborative and multidisciplinary approach for the organization of services and processes necessary for the delivery of high-quality care standardized across Memorial Healthcare System (MHS). The system wide Program Manager plays a ...
Director of Telemetry, RN
The Director assumes the role of a leader in planning, directing, and managing the department and staff to assure quality service on a 24-hour basis. ...
Executive Director
We are actively seeking an Executive Director to add to our team. The Executive Director is responsible for providing comprehensive leadership for a senior living community in operational management, goal setting and long-term growth. The Executive Director leads a team of team members with a positi...
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Provide accurate and timely regulatory guidance to all company functions while maintaining frequent contact with the Head of Regulatory Affairs. Alerts senior regulatory management of potential regulatory impact and implements appropriate internal changes. Perform other projects, project-based tasks...
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