- 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
Broad experience in US and Global Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Collaborate with regulatory affairs to support regulatory submissions and inspections.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Director will chair the respective neurology TA Global Publications Team as well as engage with cross-functional partners including but not limited to research, clinical development, marketing, market access, medical affairs, regulatory affairs and biostats.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
- Suggest Revision
The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Reporting to the VP of Program Strategy & Management, this person will work collaboratively to manage and integrate diverse R&D activities including but not limited to, preclinical research, clinical development, CMC, regulatory affairs, new product planning, business development and finance.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
- Suggest Revision
InteractionLeads engagement with internal key stakeholders (e.g. Global Medical Affairs, MCE, Region/LOCs, MPD, Global Outcomes Research and Epidemiology [GEO], and Publications) as needed. Description Objectives: The Associate Director, Global Scientific Communications, Mature Brands, is a dynamic, strategic role within Global Medical Affairs that collaborates with cross-functional partners to own one or more disease areas / assets on a Global level.
$234,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Minimum of 10 years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry. Maintain effective communication with internal and external stakeholders to ensure alignment and understanding of CMC regulatory strategies and requirements including change control.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
- Suggest Revision
MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
$3,006.98 a weekFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package ( briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions ( with FDA CDRH, EU notified bodies.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Associate Director, Regulatory Affairs reports to the Senior Director, Regulatory Affairs and executes clinical and preclinical regulatory strategies and activities.
Full-timeExpandApply NowActive JobUpdated 1 month ago
regulatory affairs jobs Title: consultant Company: Parexel in Cambridge, MA
FEATURED BLOG POSTS
How to Get a W2 From Previous Employers
When tax time rolls around, the last thing you want to worry about is having to track down a W-2 from your former employer. Many times you won’t have to because the IRS requires companies to send these forms to all current and former employees who have earned more than $600 in the last year. Unfortunately, there are employers who don’t do what they’re supposed to. There are even times where something else may happen that prevents the W-2 from getting where it’s supposed to go.
How to Ask Someone to be a Reference + Email Templates
One part of the job-hunting process that frequently gets overlooked is putting together a list of good references. Most of the time we focus on creating the perfect resume, writing an awesome cover letter, and getting our hands on letters of recommendation. We think about what outfit we’ll wear to the job interview, how we’ll answer those tricky questions, and what our career plan looks like. But, in fact, having multiple references lined up who will speak favorably about you to a potential employer is critical to landing a job. This aspect of job searching really can’t be ignored.
Job Rejection Email Response with Examples
Glassdoor estimates that, on average, there are about 250 applicants for every job vacancy out there. If you’ve ever applied for a job, the odds are that you’ve received the dreaded job rejection email.
4 Ways to Make Your Job Posting More Inclusive
According to a Glassdoor survey,
How to Calculate Net Income
Understanding your finances can be daunting even if you’re good with numbers. Your net income, in particular, is a key metric for determining how well you’re doing financially and whether your current way of operating is sustainable or not.
To ATS or not to ATS
As hiring is becoming more analytical and data-driven, companies have found ways to incorporate technology to help hire and recruit more efficiently. ATS, also known as an applicant tracking system, has become one of the most widely adopted technological recruiting tools to date. In fact, according to data from Capterra:
How to Write a Follow-Up Email for a Job Application?
Most times, we have to do more than submit a "sugar-coated" resume to land our dream jobs. Going the extra mile to follow up on your job application can increase your chances of employment. Additionally, it may even help you get confirmation sooner on whether you are seriously being considered for the job or not.