- 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 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC. Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Rocket Pharma is seeking an experienced and highly motivated Associate Director, Regulatory Affairs (USL f or AAV), who enjoys a fast paced, dynamic work environment at the forefront of innovation.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
- Suggest Revision
The Associate Director, Regulatory Affairs – CMC will be responsible for leading global regulatory CMC strategy for product development and registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) according to global regulatory expectations and requirements.
Full-timeRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities within the Regulatory group to advance development of the assets in Wave's pipeline to registration and launch; will collaborate closely with team members within the group and across drug development disciplines such as CMC, Nonclinical, Clinical and Quality.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
- Suggest Revision
At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Senior Manager/Associate Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Reporting to the Head of Regulatory Affairs and Quality. Extensive experience leading, designing, writing and submission of regulatory filings and handling correspondences (IND/NDA/MAA/CTA/CTR.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
- Suggest Revision
We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States. Minimum 8 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 5 years regulatory affairs experience including managing submissions and developing regulatory CMC strategy for development and/or commercial pharmaceutical or biological products.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Regulatory Affairs Associate is required to work on a wide variety of regulatory tasks in maintenance of technical documentation, CE marking new devices and maintaining technical files to meet Australian, Canadian and US FDA requirements.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Role : Regulatory Affairs Associate. As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global.
ExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Job Title: Regulatory Affairs Associate I. The role will aid GRLs (Global Regulatory Lead) with obtaining and creating registration documentation. Also, the role could also aid in creating draft global regulatory strategies and/or US regulatory decisions.
ExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
Promotes professional working relationship with Quality & Regulatory Affairs, Hospital Services/Distribution, Logistics, and other related departments to ensure appropriate application of regulations while improving operational efficiency.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
International Product Registration, Regulatory Affairs, Labeling review. Represent Regulatory Affairs on assigned project teams through all phases of product development, provide Regulatory Strategy and assess regulatory impact of changes on existing products.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate across functions such as Quality, Regulatory Affairs, Sterility Assurance, Extractables and Leachables, Analytical Chemistry, Product Design Owning teams, Project Management and Manufacturing.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial. Responsible for the development and implementation of global regulatory strategy and representation of Regulatory Affairs on R&D project teams.
Full-timeExpandApply NowActive JobUpdated 11 days ago
regulatory affairs associate registration jobs
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.