- 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
A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
2-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations. As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization.
RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Advanced Degree in science, law, health policy, regulatory affairs or engineering and 8+ years of demonstrated experience in device, pharmaceutical/biologics regulatory, or scientific discipline including at least 3 years of demonstrated experience specifically in regulatory affairs work.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Lead the cross functional study team for the EDODM1 Phase 1 study, including clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
- Suggest Revision
As the Director of Regulatory Affairs Operations, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will develop and lead global regulatory operations to support the advancement of multiple clinical trials.
$225,000 - $235,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
- Suggest Revision
DIRECTOR, LGBTQIA+ Student Resource Center, Dean of Students & Division of Student Affairs Tracking Code Job Description Reporting to the Associate Dean of Students in the Division of Student Affairs, the inaugural Director of LGBTQIA+ Student Resource Center (“Center”) will be charged with laying the foundation for and ensuring the immediate and ongoing success of the new Center at Boston University.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Director of Medical Affairs at Thermo Fisher Scientific will play a pivotal role in both strategically and functionally leading the North American (NA) Medical Affairs Team, undertaking the initiatives supporting the Clinical Sequencing Division (CSD) activities.
RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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 Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
Full-timeExpandApply NowActive JobUpdated 4 days 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.
ExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: sr regulatory affairs associate in Arlington, MA
FEATURED BLOG POSTS
Collaborative Recruiting: The Key to a Better Talent Acquisition Strategy
Talent acquisition is a multi-stage process where candidates undergo various application steps before getting hired. The unfortunate reality is that it is a labor-intense system, with the hiring manager and recruiter often handling all of the work on their own. Ask any one of them, and you will hear about the overabundance of applications and the demanding task of filtering through them to find the best candidates. The quality of talent suffers under the weight of all that work on one person's hands. It's not easy, but as many companies are starting to realize, there is a better way. The future of talent acquisition lies in collaborative recruiting!
4 Talent Acquisition Trends Going Into 2023
For better or worse, a side effect of the COVID-19 pandemic was a marked shift in talent acquisition practices worldwide. With the struggle to retain talent that began in 2020, companies have had to rethink recruitment strategies. The result has been new talent acquisition trends that are well on their way to becoming commonplace. These are the practices that are going to become even more widespread going into 2023.
Why is Professionalism Important & How to Be Professional
You might have heard the word professionalism thrown around in the workplace, but do you know what it means? And do you know how to maintain professionalism no matter the circumstances?
Why Cover Letters Are Important & How To Write One | Job\Searcher
Most people completely waste their cover letter real estate. Your cover letter is another opportunity to speak directly about how your background and capabilities align with the opportunity you seek. It also allows you to introduce your personality a bit more than a resume does. So, why are cover letters important? Because you can stand out, big time, with a custom cover letter directed to the right person.
Hiring Again After Mass Layoffs
It's never an easy decision to let members of your staff go, but depending on the state of your business, mass layoffs may have been the only way to survive. Now that you're months into the future, you may find yourself itching to start hiring again after previous layoffs.
Why Are Internships Important & How Can You Get One?
Internships are for college students or people who have just completed their degree. If you are a student or recent grad, you may be wondering how to land an internship. If you've never had one, you may even wonder if you need one. After all, didn’t you work in that call center while also doing exams? Or perhaps you’ve bartended your first year in college?
Why is Networking Important & How to Network Effectively
Even if you’ve worked hard to earn a degree from an impressive school, landing your dream job might still come down to who you know – otherwise known as networking. Lots of qualified candidates might apply for a job, but the person who gets it might very well be so-and-so’s sibling, friend, or kid. Sometimes the only way to get your foot in the door is to know someone.