- UpvoteDownvoteShare Job
- Suggest Revision
Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product. The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product.
$200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Lead the development and implementation of global CMC regulatory strategy supporting CGT products. The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems, and a range of cell therapy products.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Sr. Medicare Compliance Program Manager is a key member of the Legal, Regulatory Affairs and Compliance team to support the organizations Medicare Advantage line of business. Advises Medicare Compliance Officer regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package (e.g. briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions (e.g. with FDA CDRH, EU notified bodies.
$200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Director, Model Validation for Santander US Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR11-07 and other regulatory requirements around Compliance models.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs. Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA.
ExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
Our Client's FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Appeals and Grievance Specialist is responsible for managing the resolution process of medical and pharmacy member appeals and/or member generated complaints/grievances, and ensuring compliance with contractual obligations, regulatory requirements and accreditation standards.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Strong knowledge of and/or experience with government programs regulatory, operational, financial, and clinical requirements for the delivery of health insurance and managed care products and services, including Medicare, Medicaid, MMP, LTSS, SNP, Duals, CHIP and behavioral health, as well as the associated and relevant federal, state and local regulatory entities.
RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Familiarity with regulatory requirements and compliance in equity capital markets. This is a brand-new role for the firm, reporting to our CO-Chief Investment Officer and will offer an exciting opportunity to become a pivotal partner in shaping our equity capital markets strategy.
$250ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
5+ years of experience as in-house counsel advising product teams and/or leading regulatory coverage preferably in fintech or institutional financial services. You will partner with innovative product teams harnessing the power of crypto assets and blockchain technology to develop the new financial account for businesses and help plan and implement regulatory strategy against the evolving regulatory landscape for stablecoins and other digital assets.
$180,000 - $237,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Consumer lending product knowledge (e.g., mortgage, auto, credit card), consumer lending life cycle knowledge (e.g., marketing, origination, pricing, risk and servicing), consumer regulation knowledge (e.g., fair lending, CRA, UDAP, TILA, RESPA), regulatory requirements of the Federal Reserve, OCC, OTS and/or FDIC.
$108,300 - $198,600 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory job Title: principal Company: Parexel in Cambridge, MA
FEATURED BLOG POSTS
5 Common Interview Mistakes
Everyone's interview process is unique in some form or fashion. Like most, your interview process is crafted so you can get the most information out of your candidates to increase hiring confidence and make the right hiring decisions. However, there are often small problems in interview processes that could ultimately affect the success of hiring decisions.
How to Write a Job Description?
It might be tempting to overlook the importance of a well-written job description. After all, if you’ve posted job ads before and ended up with tons of resumes in hand, it’s easy to assume that this will always be the case, regardless of how your job ad reads. But, in reality, you really can’t take getting an influx of resumes for granted.
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.
Structured vs Unstructured Interviews
The goal of an interview is to evaluate candidates based on their skills, personality, and knowledge. You want to choose the BEST candidate from your candidate pool, so the interview is something you can't mess up. As you begin planning your interview process, one of the major decisions you'll face is whether the interview should be a structured vs unstructured interview. So let's take a dive into the differences and sort out which circumstances warrant which interview process.
How to Describe Your Personality with Examples
Imagine you’re in an elevator with the CEO of your dream company and you get to talking. The conversation is going well and you start to imagine yourself working for their company when the CEO turns around and asks you “tell me a bit about yourself.” Would this catch you off guard or would you be able to give a clear and succinct description of who you are?