- UpvoteDownvoteShare Job
- Suggest Revision
Provide strategic and regulatory compliance input on technical protocols, reports, and other source CMC documents. Escalate issues to Senior Management that may impact regulatory compliance and continued development of assets.
$215,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The compliance specialist will also support, QMS and cross train within the quality departments. Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance to meet timelines while ensuring cGMP and regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
- Suggest Revision
As a trusted resource and extension of our client’s tax compliance environment, this role performs tasks such as data imports and reconciliation, management of regulatory tax deadlines, and provides problem resolution to complex problems.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Ensure regulatory compliance with existing guidelines and expectations through timely assessment of change controls and deviations, and timely completion of quality trainings. 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 20 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Expertise in regulatory submission structure and content (e.g. IND, CTA, MAA, NDA, BLA). Dragonfly Therapeutics is seeking a Head of Regulatory Affairs, title commensurate with experience, and reporting directly to the COO, to lead our Regulatory Affairs organization.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Compliance Officer will work closely with leadership to ensure compliance considerations are factored into day-to-day operations and strategic planning including leading regulatory compliance and oversight of accreditation programs and initiatives.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Monitor changes in the business and regulatory environment and assess their impact on SOX compliance. 5+ years of experience in internal audit or SOX compliance. Provide training and guidance to employees on SOX compliance requirements.
InternExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Minimum of 5-7 years’ experience in human subject/clinical research including at least 1-2 years of experience clinical trial monitoring/auditing, research compliance, or regulatory oversight/project management of human subject research protocols.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
- Suggest Revision
As a Regulatory and Litigation Counsel, Competition you’ll join an Americas-based team that leads the strategy for defending the company in responses to governments and regulators. Lead responses to regulatory inquiries, investigations, litigation, enforcement actions, and overlapping of civil matters.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Working closely with the Global Regulatory Lead, Regulatory Operations, and cross-functional teams, the Senior Manager will ensure timely submission of high-quality data packages to global health authorities.
$80 an hourExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
This role is critical for establishing effective regulatory strategies across ModeX programs and for ensuring compliance with applicable regulations and guidelines set forth by regulatory authorities such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory’s Quality Management System for domestic and various international markets for SaMD products.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate cross-functionally with internal teams, including clinical, clinical operations, quality assurance, pharmacovigilance, and non-clinical, to prepare, review, and submit high-quality regulatory submissions, including INDs, NDAs, BLAs, and other relevant applications, ensuring compliance with regulatory requirements and timelines.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Reporting to the Vice President, Global Regulatory Affairs, the Director of Regulatory Operations will lead global regulatory operations, managing the submission process for regulatory filings and ensuring compliance with regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Oversee preparation, review, and submission of regulatory documents maintaining compliance with regulatory requirements. The Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs.
Full-timeExpandApply NowActive JobUpdated 16 days ago
Title: regulatory compliance Company: Flybreeze in Lexington, MA
FEATURED BLOG POSTS
Internal Recruiting: Benefits and 5 Internal Recruiting Methods to Consider
Internal and external recruiting are nearly the same thing. The biggest difference is where candidates are sourced. There are instances where external recruiting may be the best option. However, when you are presented with the opportunity to recruit internally, you should take full advantage of the different internal recruiting methods. Initially you will find that the hiring process gets a little bit easier. Then you'll notice all the other benefits that internal recruiting offers.
How to Answer the Interview Question: What is Your Communication Style?
As a job searcher, you probably have so many questions about job searching. However, once you've landed an interview, your excitement takes your questions to a whole new level. What will you wear? Will you know how to answer all the questions? Have you practiced giving nice firm handshakes?
What Makes a Company a Great Place to Work
After one too many after-hours emails, you’re on the hunt for a new gig. But what makes a company a great place to work? And how will you know when you find one? Finding a motivating, safe, and productive work environment is important for our mental and physical health. If you’re financially frustrated, creatively stuck, or just plain over it, it’s time to find a healthier workplace where you can flourish.
What Makes a Good Boss? The Top 12 Qualities & Attributes
Think back to the best boss you’ve ever had—does someone come to mind? We hope so! Okay, now think back to the worst boss you’ve ever had. I’m sure you can conjure up a few faces.
How to Recruit and Retain Gen Z Employees
As Boomers and the oldest Gen X are exiting the workforce, younger Millennials and Gen Z are flowing in. While the younger generations seem to be completely different than the older generations, many care about some of the same things- financial security, working conditions, etc. However, due to social and cultural differences in the era that Gen Z has grown up in, they have concerns that were never even workplace topics of discussion 20 years ago.
How Does Temp to Hire Work? Benefits, Concerns, & More
Whether you’re just starting out your career or are looking for the next opportunity, the job market has never been more burgeoning with opportunities. From flexible work options and freelancing gigs to seasonal and temp-to-hire work, people today are spoiled for choice when it comes to finding engaging and fulfilling work.
Explore Your Skill and Find the Best Way to Make Money From Home
When you just can’t stomach another drive-thru coffee on your morning commute, close your navigation app on your phone and search for easy ways to make money from home instead. With a computer and some niche skills, there are countless opportunities for you to earn a living from your couch. (Okay, fine, your home office.) Below, we’ll explore 30 different ways to make money from home, as well as a few “too-good-too-be-true" warning signs to know to keep you from booking the wrong remote gig.