- UpvoteDownvoteShare Job
- Suggest Revision
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
Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
Full-timeExpandApply NowActive JobUpdated 6 days ago - 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
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
Environmental Permitting: Assist clients in navigating the regulatory permitting process, including obtaining permits for activities such as air emissions, wastewater discharge, wetland impact, and hazardous waste management.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Familiarity with the environmental considerations, permitting processes, and regulatory requirements specific to offshore wind developments. Regulatory Compliance: Stay up-to-date with federal, state, and local environmental regulations and ensure that consulting projects adhere to all applicable laws and guidelines.
Starting at $250ExpandApply NowActive JobUpdated Yesterday - 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.
ExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
ExpandApply NowActive JobUpdated 29 days ago - 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
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 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
In collaboration with Academic Affairs, responsible for understanding and assessing teaching and learning needs; and making recommendations on how the learning management system can be used to support those needs.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
G, clinical operations study team members, regulatory affairs, quality assurance, and information technology) to ensure TMF compliance and quality) Manage the Trial Master file in compliance with regulatory requirements and company SOPs.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvote
Clinical Director in Translational Medicine, Cardiovascular & Respiratory Early Clinical Development
Share Job- Suggest Revision
As a key member/leader of an early development team, working in close collaboration with internal and external staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) for the design and execution of early clinical development strategy.
$247,700 - $390,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
Full-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: principal in Cambridge, MA
FEATURED BLOG POSTS
How Does Salary Range Work (With Examples)
What are your salary expectations? Do you know? Establishing a salary that compensates you fairly and keeps you happy at work can feel like taking a shot in the dark. And employers sure don’t make learning budgets easy!
Guide to Hiring a Teenager
Teenagers are full of life. They bring energy and adaptability that may be hard to get from older workers, but does that mean that hiring teens is beneficial? Well, it depends. As you debate whether or not you should integrate teenagers into your workforce, there are some things that you should know first.
10 Best Tips to Find a Job When Relocating
Are you planning to move? That’s great news, but now you might wonder what that means for your job. Some people are lucky – they can relocate and keep working the same position as always, just remotely. For others, however, this isn’t an option. They must search for and land a job in their soon-to-be new city. This can be intimidating, given that getting a new job even under normal circumstances can be challenging. Now you’ll have to overcome additional hurdles. This article provides valuable tips on how to find a job in another state. Because it can be done! Read on to learn how.
How to Re-apply for Your Old Job Professionally
Have you recently started a new job only to find that you miss your old one? Maybe you didn’t realize how good you had it, and now you regret leaving. Don’t worry. You’re not the first person to feel this way, and you might even be able to return to your old job if you play your cards right.
Looking for New Candidates?
Before the turn of the century, recruiters could put their "help wanted" ads in the newspaper, and applications would pour in. Since then, recruiting has turned a new page. The use of the internet and other technologies allows recruiters to broaden their candidate pool for the simple reason being
Decline a Job Offer Professionally: When to Rescind
Your job search has finally paid off! After countless job applications, numerous emails, and several interviews, the hiring manager and other stakeholders have decided that you’re the right person for the job! All you have to do now is accept the offer and walk into the sunset, right?
Resume Job Description Samples - 8 Tips to Follow
When looking for a job, your resume becomes a crucial element. From making a great first impression to showcasing all your achievements and potential, your resume has to portray your professional story in minutes.