- UpvoteDownvoteShare Job
- Suggest Revision
May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Large MLTC program with locations around NYC, is currently seeking an experienced Regulatory Affairs Associate to join their dynamic and dedicated team. Regulatory Affairs Associate – MLTC Program - Hybrid.
$125,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
- Suggest Revision
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.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
You will provide global product stewardship and regulatory affairs services for a line of chemical products that support Videojet printers. Manage our SDS, label, and regulatory affairs systems.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
$7,500 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Job Description PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
We are seeking a global Executive Director, Regulatory Affairs, Cell Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Block is looking for an experienced policy and regulatory strategist to serve as our Head of Regulatory Affairs. Maintain fluency on a variety of regulatory and policy issues at the intersection of financial and technology policy, including financial regulation, consumer protection, tax, cryptocurrencies, AI/machine learning, intellectual property, and privacy.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
- Suggest Revision
With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development, approval and post approval processes and commercialization, in coordination with internal staff, Japanese colleagues at Taiho Pharmaceutical Corporation (TPC) and external consultants/contractors.
$197,000 - $232,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - 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.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
ExpandApply NowActive JobUpdated 10 days ago
regulatory affairs jobs Title: intern Company: Merck
FEATURED BLOG POSTS
What Are SMART Goals?
When it comes to achieving our goals, there’s a lot of noise to work through. A study by the University of Scranton has found that only 8% of people who set New Year’s resolutions actually achieve them. Our busy lives might be one reason for this. Another, even more important reason, is our approach to goal setting. Being too vague, too ambitious or simply unclear on the timeframe can set us up for failure.
How Long Do Background Checks Take for Pre-Employment
Many jobs require a background check. For some companies, this is a matter of company policy. In other jobs, such as finance, childcare, and security, the government often requires background checks. While there are varying levels of intensity, for most people, a background check is nothing to worry about. In fact, the biggest question is often how long does a background check take? Here’s what job seekers and applicants need to know about background checks before they apply to new jobs.
The Best Remote Jobs: Where & How to Find Them
The Covid-19 pandemic hasn’t been easy on any of us, but if there’s one silver lining, it’s the fact that remote work has grown in popularity because of it. Companies that previously weren’t open to their employees working remotely were suddenly forced into allowing it. Since then, they've realized that much of their workforce is happier and more productive. Naturally, this has led to more remote job openings, which is great if you’re interested in this type of position. Read on to learn more about the best remote jobs and where to find them.
In-House vs Outsourcing Recruiting: Which is Better?
When looking at in-house vs outsourcing recruiting, it is important to nail down the benefits for each and whether those benefits outweigh the risks that follow.
How to Write a Short Bio
First impressions can be tricky. When meeting someone in person, it’s likely you have an elevator speech. These short, practiced introductions can help you share more about who you are, what you do for work and other facts about you. While this works well in a live, in-person context, there are many cases where professionals “meet” someone via written form - like social media, a resume, or published work. In these cases, your bio works as your first impression. So, here’s a step-by-step guide on how to write a short bio.
How to Effectively Recruit Employees
Today, hiring and retaining talent looks much different than it did only two or three years ago. Financial instability and the strain on our mental health brought on by the pandemic has made everyone more wary and selective of their workplace and employer. Whereas in the past people might have prioritized promotions and financial reward, today they look at other factors such as workplace flexibility, personal fulfillment and values alignment.
How Many Hours is Part-Time vs. Full-Time Work?
Growing up you watched your parents shuffle to and from the office, held hostage to their 9 to 5. If jammed-packed schedules and deadlines sound frightening, you might consider pivoting your search to part-time jobs. In fact, even employers have shifted their preference, selecting more people open to the idea of flexible working hours.