- UpvoteDownvoteShare Job
- Suggest Revision
Partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operations and Quality Assurance in support of the study project teams and ensures timely supply for clinical trials.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Director is a highly visible role and will closely collaborate with cross-functional partners including Regulatory, Clinical Research, Clinical Operations, Biometrics, Medical Affairs, Patient Advocacy, and Commercial to successfully incorporate HEOR strategies and RWE to support the development and commercialization of Paltusotine.
$230,000 - $287,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Regulatory Affairs Sr. Director’s role leads regulatory strategy, regulatory filings and health authority interactions to support oncology products. This position will focus on nonclinical and clinical regulatory aspects of product development.
$242,000 - $285,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Responsible for the financial management of expenses and labor quality assurance/CQI regulatory affairs training and education of staff and development of an excellent customer service center.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
This is a newly created individual contributor position within the recently established Global Significant Remediation Oversight and Governance team as part of the Global Regulatory Affairs Office.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
$221,170 - $286,220Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Manages appropriate levels of interface with Regulatory Affairs, Clinical, Quality, Marketing, Operations and Research & Development. Instills a sense of urgency to ensure goals are met in a timely manner while meeting regulatory, quality, and customer requirements.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
As part of this opportunity, the incumbent will work with functional groups including Regulatory Affairs, Quality Assurance, Marketing, Packaging and Manufacturing to develop requirements for labeling text.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Our Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients' needs. This position will report into the US Medical Immunology team which is a segment of the Medical Affairs Specialty Care organization.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
What You Can ExpectAs the Vice President, Government & Regulatory Affairs in Washington, DC you will be the primary representative for ENGIE North America’s interest before US legislators and regulators, regional transmission organization and independent system operators and their stakeholder processes, regional, and municipal government officials, and industry associations.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Transamerica is organized by lines of business (Life Insurance, Annuities, Mutual Funds, Retirement Plans, and Employee Benefits), which are supported by Transamerica Corporate (Corporate Development; Finance; Internal Audit; Legislative, Regulatory & Policy; Office of the CEO; People and Places; Brand; Corporate Affairs; Risk; and Technology.
Work from homeExpandApply NowActive JobUpdated Yesterday - 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. Support CMC sections of major, complex regulatory submissions, including Investigation New Drugs (INDs), Investigational Medicinal Product Dossier (IMPD), New Drug Applications (NDAs), Marketing Authorization applications (MAAs), Quality Overall Summaries (QOS), and Biologics License Applications (BLAs.
Full-timeExpandApply NowActive JobUpdated 3 days ago - 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
Leading without authorityAble to effectively communicate on regulatory topics both internally and externallyShows flexibility and is open to adaptable to changeBS or equivalent with 10+ years of related experiencePrior regulatory affairs experience in major markets is expected#LI-RemoteThis position is remote.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Partner with business affairs leadership to assist with contract and licensing workflows, risk management and other compliance matters related to vendor relations and project execution. Prepare routine payroll reconciliations and audits for management and regulatory agencies; including workers' comp audits.
Full-timeExpandApply NowActive JobUpdated 4 days ago
regulatory affairs jobs
FEATURED BLOG POSTS
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 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.
Technology in the Workplace: How to Improve your HR Function with AI
It’s safe to say that the last two years have brought fundamental changes to the way we work and do business. Companies have relied on technology in the workplace to digitize their services and build a remote-friendly infrastructure that could prepare them for the future.
4 Things to Consider When Building a Global Workforce
The rise of remote work has given employers a unique chance to rethink how they approach workforce management. This ranges from rethinking the size and design of their office space to updating their tech stack to accommodate different working styles. It has created new opportunities for companies of all sizes to expand their hiring pool and look for top talent on a global scale.