- UpvoteDownvoteShare Job
- Suggest Revision
The role will report directly to Senior Vice President of Regulatory Affairs at Ultragenyx. A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California page is loaded. Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
RemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) page is loaded. as part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division HQ location in Alameda, CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
We are looking for an Associate Director of CMC Regulatory Affairs. JOB TITLE: Associate Director of CMC Regulatory Affairs. Associate Director of CMC Regulatory Affairs.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. You're the right fit if: You’ve acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K’s, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Regulatory Affairs representative for the CT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
A scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
$237,660 - $307,560ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate with internal project team to facilitate IND/CTA document authoring and review workflows including SharePoint and Master Control responsibilities for regulatory affairs and CMC regulatory.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
The Manager of Regulatory Affairs at AES Clean Energy (AESCE) will be tasked with supervising AESCE's positions and fostering relationships within the Federal Energy Regulatory Commission (FERC), managing policy positions within Regional and Independent Transmission Organizations (RTO/ISO), and taking the lead on filings and policy positions at state Public Utility Commissions (PUC) or Public Service Commissions (PSC) in key states.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
ExpandApply NowActive JobUpdated Yesterday
regulatory affairs jobs Title: senior manager regulatory Company: Aldevron
FEATURED BLOG POSTS
Is There a Slow Decline of the Labor Market and Wage Growth?
BLS data from January 2023 to March 2023 states that,
2023 Quarterly Review: What’s Happening in Recruitment?
It’s that time again. It’s your quarterly review. Get excited because this is a great time to review some of the amazing accomplishments you and other pros like you have made in recruitment for 2023 thus far! Despite recruitment challenges, things are starting to balance out in the candidate market - partly because of the brilliant ideas and methods being used.
Project Coordinator Resume Guide with Tips and Samples
Project coordinators fall within the field of project management, which tends to be a field with a lot of opportunity. In short, project coordinators differentiate themselves from project managers due to the responsibilities related to their work. While project managers have a hands-on approach for managing a team, project coordinators ensure the success of a project from the background. They handle administrative and organizational tasks related to delegation, establishing project objectives, or performing digital administrative tasks.
Land a Production Supervisor Job With These 5 Resume Tips
Have you been working as a team lead on a factory floor or in a manufacturing plant for several years? Do you consider yourself a leader who excels at managing and coaching others? Can you monitor and optimize production processes? Do you recognize the importance of employee safety and compliance? If you’re answering yes to all of these questions, then you’re definitely in the right place.
Assistant Manager Resume Guide
It can be very challenging for many individuals to find a job in the current economy. As a result, the unemployment rate is only starting to decrease after being at its highest since the Great Depression. One of many reasons this is occurring is because this pandemic has encouraged people to quit their jobs to search for better working conditions, become entrepreneurs, or change careers.
The Ultimate Guide to Writing a Stellar Sales Manager Resume
Have you been working in sales for several years now and feel ready to move up the career ladder? Do you enjoy leading sales teams and developing strategies to drive company sales? Would you describe yourself as a strong communicator, negotiator, and closer? If so, then there’s a good chance that a sales manager position might be the ideal fit for you.
The Ins and Outs of Building a Resume From a Bar Manager Job Description
Many people turn their noses up at bartending jobs, as they do for most jobs in the food service industry. Little do they know, bartenders possess a lot of unique skills. Even though these jobs can require little to no education, bartenders must go through extensive training or schooling. Additionally, the demand for these jobs is extremely high, and the career growth opportunities often bring bartenders into management positions after years of experience.