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...
Director, Regulatory Affairs
Develop and formulate innovative regulatory and technical corporate policy positions in coordination with global technical policy advocacy teams and with US Engineering and Government Affairs leadership on regulatory issues including memoranda, fact sheets, comments for regulatory hearings and admin...
Director, Regulatory Affairs
This role serves as the lead regulatory and technical policy coordinator for emissions and electrification topics in the US, working under joint coordination with Vice President, Engineering and Environmental Office (~70%) and Senior Vice President, Industry and Government Relations (~30%). This rol...
Research Regulatory Specialist Sr (100% remote)
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
Senior Regulatory Associate US Regulatory Affairs
A company is looking for a Senior Associate in US Regulatory Affairs. ...
Regulatory Affairs Associate
As a Regulatory Submissions Coordinator, you will be responsible for coordinating and preparing document packages for regulatory submissions across all organizational areas. Job Title: Regulatory Submissions Coordinator. Staying updated on regulatory procedures and changes will be crucial to your su...
IT Transition Program Manager
The Program Manager leads the team or teams responsible for delivering a program’s products, services, and outcomes and is accountable for the overall success of the program. Ensure that overall transformation program structure and program management processes enable the program and its component te...
Affordable Housing Compliance and Training Specialist
AGM Management is currently accepting resumes for an experienced Affordable Housing Compliance and Training Specialist to assist with the Project Based Section 8 and Low-Income Housing Tax Credit Regulations. The Affordable Housing Compliance and Training Specialist takes the lead role in auditing,...
Sr. Director, Global & Executive Compensation Dearborn, MI, United States (On-site) Posted on 0[...]
Director, Global & Executive Compensation possesses extensive knowledge of designing, executing, and administering corporate and/or regional compensation programs. Leads briefings and meetings with senior HR and business leadership on matters pertaining to the compensation function like executiv...
Executive Director - Livonia
The Livonia Housing Commission (LHC) is seeking a highly qualified Executive Director to lead and manage its portfolio of 393 owned housing units, 979 housing choice vouchers, and 25 foster youth vouchers. Candidates should have at least five (5) years of executive housing/community development mana...