- UpvoteDownvoteShare Job
- Suggest Revision
Has strong working knowledge of clinical study processes and related regulatory requirements or information governance frameworks, (e.g., 21 CFR Parts 11, 312, 314, Good Clinical Practice [ICH-GCP E6 R2], Good Clinical Data Management Practices, HIPAA, GDPR, etc.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The American Heart Association has a phenomenal opportunity for a Regulatory Affairs Manager with our Federal Advocacy Team in our Washington, DC office (home-based work arrangements available.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
The Director of Global Regulatory Affairs CMC is responsible for the development and execution of global Chemistry, Manufacturing, and Control (CMC) regulatory strategies that support the success of products throughout their lifecycle.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Consistently adheres to regulatory and compliance policies and standards linked to the job as listed and complete required compliance trainings. An AML Investigations Manager assists the Bank Secrecy/OFAC Officer and the Director, Financial Investigations Unit with maintaining certain aspects of the Bank's BSA/AML compliance program and assists in meeting and maintaining BSA/AML compliance requirements of the Bank. Complies with all applicable, federal and state laws, regulations and guidance, including those related to Anti-Money Laundering (i.e. Bank Secrecy Act, USA PATRIOT Act, etc.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate closely with colleagues in Legal, Administration IT, HR, Finance, Shared Services, Sales and Marketing, Compliance and Regulatory and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution, reporting and remediation.
RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
A minimum of 10 years of experience in Regulatory Affairs, CMC Biologics (Bachelor's degree requires at least 12 years) Work with VP of Regulatory Affairs to identify resource needs, including consultants and new associates, advising on skills sets to meet needs.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Principal Regulatory Affairs Specialist. 7+ years of Medical Device Regulatory Affairs experience, domestic and international or equivalent experience. Propose solutions for Regulatory Affairs questions/issues to RA management.
ExpandApply NowActive JobUpdated Yesterday - 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
The Regulatory Specialist Contractor provides technical expertise and support in food product labeling, nutrition, and regulatory guidance for Ferrara. fda, sap, regulatory, food regulatory, nutrition fact panels, ingredient statements, dragonfly, food label review software, product lifecycle management plm software, artwork review.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
As a Regulatory Affairs Manager in Gaithersburg, MD, you'll play a pivotal role in channeling our Scientific capabilities to make a positive impact on changing patients' lives. Regulatory Affairs Manager in the Gaithersburg, MD area.
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.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Join Takeda as an Associate Scientific Director where you will work in the Gastroenterology Drug Discovery Unit (GI DDU) and will operate within a highly-functional team focused on the discovery and development of novel drug candidates for the treatment of chronic liver diseases.
$102ExpandApply NowActive JobUpdated Yesterday
Title: regulatory affairs Company: Takeda Pharmaceutical Company Ltd
FEATURED BLOG POSTS
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 Conduct a Performance Review (With Examples)
In a world where the smallest mistake can cost your business tens of thousands in lost revenue, your talent is key to keeping your edge on the market and driving growth. However, managing a workforce of any size can be a challenge. Employees come with their own particular skill set, ambitions and flaws. So, it can be difficult to uncover their individual drivers. Not to mention the challenges brought on by the hybrid and remote working models where in-person interactions have become few and far between.
How to Recruit Passive Candidates
Learning to recruit passive candidates is a different ballgame than recruiting active ones. While an active candidate is someone who is currently looking for a new job, a passive candidate tends to be the opposite. Passive candidates are either already working or not looking to work. So, instead of these candidates coming to you, you'll have to find them and reach out to them first.
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.