- UpvoteDownvoteShare Job
- Suggest Revision
A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
All fellows will complete a fellowship project for presentation to the Regulatory Affairs department and/or at a key conference/congress. The fellow will report to the fellowship track manager within the Regulatory Affairs – Therapeutic Area team throughout the one-year program.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
$315,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Advanced life science degree or certification in Regulatory Affairs Sciences preferred. In this role, a typical day might include:The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as disseminate relevant regulatory intelligence information to Regeneron stakeholders.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
This position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and author high quality regulatory submissions to health authorities and will have frequent interaction with internal senior management, corporate partners, international regulators and external experts.
$329,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
$286,700 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Knowledge of HUD programs, regulatory compliance, the affordable housing industry, the Austin/Travis County Homelessness Response System, and the Homeless Management Information System (HMIS). The qualified candidate will coordinate service through the Veterans Affairs Supportive Housing (HUD-VASH) program and other rental assistance programs.
$70 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
More details on our benefits can be found on our website at to the Chief Compliance Officer, the Assistant General Counsel - Regulatory Affairs provides legal support to each of ITW’s Segments and Corporate functions as needed on a variety of regulatory matters, with a principal focus on monitoring and advising ITW businesses regarding existing and developing legal and regulatory issues affecting the company’s operations and products.
ExpandApply NowActive JobUpdated 6 days ago
regulatory affairs jobs Title: regulatory affairs project manager Company: Integrated Resources Inc
FEATURED BLOG POSTS
How to Pass a Personality Test with Flying Colors
Whether you’re applying for your first job or looking to move up the career ladder, personality tests aren’t usually the first thing we think about. But surprisingly, they can have a massive impact on how our future employers perceive us. In fact, a 2017 study by the Society for Human Resource Management (SHRM) has found that 32% of U.S. employers use personality tests when hiring for senior management positions, and 28% use them for middle management positions. Personality tests are also used for hourly workers and contractors, though less frequently.
10 Practical and Effective Strategies to Persuade Anyone of Anything
Learning how to persuade people is like a key that can unlock any door. Acing the interview for the job of your dreams. Getting the best deal on a new car. Closing a sale with a skeptical customer. All of these wins require a level of persuasiveness.
How to Write a Recommendation Letter for a Student
When a student applies for their first job or for their next academic degree, they don’t have much experience to showcase their skills and personal qualities. Hiring managers and admissions officers, therefore, often look at recommendation letters as a way to go beyond the student’s GPA and learn more about the student’s skills and personal qualities.
How To Answer “Why Do You Want to Be a Supervisor” in an Interview
Anyone who has worked in a supervisor role knows how challenging yet rewarding it is. But chances are if you're trying to become a supervisor, you'll be forced to answer:
What is Career Cushioning?
Is your organization prepared for “career cushioning”?
How to Gracefully Quit a Job You Just Started
You’ve just started learning the ropes at your new job, and you've gotten to know your colleagues. But you’re already thinking about quitting. Maybe you were deciding between to job offers and realized that you’ve made the wrong choice. Or, a change in your personal circumstances means that you have to quit.