- UpvoteDownvoteShare Job
- Suggest Revision
15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
$113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Our client is looking to fill the role of CMC Regulatory Affairs Manager. CMC regulatory requirement knowledge specifically for biologics and small molecules – development through post approval.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Work collaboratively with Pharmaceutical Science for drug substance and drug product development, GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions (such as Drug Product Development, Drug Substance Development, Analytical/QC, and Quality teams.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Leads the regulatory team in the development and compilation/publishing of documentation for U.S. FDA investigational new drug (IND), European Medicines Agency clinical trial application (CTA)/investigational medicinal product dossier (IMPD), Abbreviated/New Drug Applications (A/NDA), and biologics license application (BLA) submissions, FDA meeting requests, and correspondence and responses to questions from regulatory authorities, including FDA.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Leads Regulatory Affairs for sterile injectable, non-sterile, and biologic/biosimilar product development (including biologic/device combination products), review, submission, and FDA approval of Civica’s medication portfolio.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
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
Collaborate effectively with colleagues from various disciplines including Medicinal Chemistry, Pharmacology, and Regulatory Affairs to achieve project goals. Ph. D. in Organic Chemistry (or related field) with 5+ years of biotech/biopharma industry experience in small molecule drug substance development; or M.S. with 8+ years of relevant experience.
$184,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Regulatory CMC experience leading both development projects (IND/CTA) and initial registration (BLA/MAA). Provide CMC regulatory expertise to enable global development and registration for INDs, CTAs, BLAs and MAAs.
$329,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Interface effectively with all other BMS internal stakeholders: Global Medical Affairs functions and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs, Managed Care, Pharmacovigilance, Market Access, Statistics, Translational Research/Development, Project Leadership, etc.
Full-timeExpandApply NowActive JobUpdated Yesterday - 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
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 packages (including participating/leading HA meetings); and/or post-approval submissions.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Proven ability to collaborate across departments (Clinical Operations, Translational Research, R&D, Regulatory Affairs, Finance, Manufacturing, Process and Analytical Development.
$350,000 a yearExpandApply NowActive JobUpdated Yesterday
regulatory affairs drug development jobs Title: regulatory affairs manager Company: Kyowa Kirin North America
FEATURED BLOG POSTS
How to Build a Supervisor Resume
Writing a great supervisor resume doesn't have to be rocket science. All you need to do is figure out what the company requires and how best to appeal to their needs. In other words, see the resume as your “key” into any organization of choice.
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.
How to Write a Chief Operating Officer Resume + Sample
Are you looking to become the Chief Operating Officer in your company of choice? Do you want to create a compelling COO resume that will earn you the job? This article is for you.
Spotting the Details to Build a Construction Project Manager Resume
So you’re ready to become a Construction Project Manager! To achieve this goal, you need to find the right role and write the best resume you can to show a prospective employer that you’re a great fit.
6 Tips to Create a Management Consulting Resume + Sample
So, you want to land a job as a management consultant? Well, here is a management consultant resume sample and some tips below. This will help you create a mind-blowing resume that will keep you in the spotlight during recruitment.
Get Ready, The Beginning of the Year is the Best Time to Job Search
Frankly, if you need a job, the best time to apply for one is right now. But, regardless of timing, the competition is fierce and job seekers should do everything they can to score an advantage. Understanding when companies hire, the typical hiring season trends, and the right time of year to apply for jobs will give you the best chance at success.
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.