- UpvoteDownvoteShare Job
- Suggest Revision
Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Dorsey is seeking a Regulatory Affairs Associate with four to six years of experience to join our Anchorage office. Among Dorsey’s many distinguished alumni are U.S. Supreme Court Justice Harry Blackmun, noted law professor and scholar William Prosser, Minnesota’s first woman judge Betty Washburn, former U.S. Vice President and Ambassador to Japan Walter Mondale, U.S. Senator Amy Klobuchar, former Corporation Counsel of the City of New York Zachary Carter, and U.S. Secretary of Agriculture Tom Vilsack.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
- Suggest Revision
This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including global/regional/local HEOR leaders, Department Heads, TA Heads, CMT Leads, Development, Regulatory Affairs, and Market Access.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
This position works closely with the Regulatory Affairs Manager and requires daily interaction with physicians, research staff at collaborating institutions, pharmaceutical company sponsors and any other groups integral to the successful completion of research projects.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety and Infection Prevention & Control to review clinical evidence and to evaluate a product’s risk-benefit calculus.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Provide legal advice and support for our U.S. businesses and Environmental, Health, & Safety team covering a broad range of environmental, safety, and regulatory issues. 5 to 15 years practicing law with experience in environmental or regulatory work (5 years of law firm/private practice experience preferred.
$190,000 - $240,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
The Manager of Quality Assurance and Regulatory Affairs, Laboratory Services provides CLIA compliance in a clinical lab setting supporting clinical testing services and projects. 5-7 years of quality assurance or regulatory certification experience in a CLIA and/or GCP / GLP laboratory environment.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Medical Affairs: TA Heads, Executive Directors, CMT leads, ESMA leads, Senior Medical Directors/CMT members, HEOR Leaders. Provide oversight and strategic and scientific input for HEOR projects, data interpretation, protocol development, regulatory documents, scientific publications, and independent research proposals for assigned products.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Develops, updates and maintains installation EFMP education, outreach and public affairs programs, to include awareness briefings for command, unit, community organizations, individuals and families and distinguished visitors.
Part-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
The Director of Quality & Regulatory reports directly to the VP, Medical Affairs. The Director, Quality & Regulatory is responsible for ensuring the implementation of quality assurance operating procedures, ensuring the completion of quality assurance/quality improvement assessments monthly, and monitoring quality improvement/quality assurance outcomes.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Within HPDs Office of Legal Affairs, the Regulatory Affairs Division (RAD) provides legal support services for the Agencys regulatory and enforcement functions and advice on compliance with external City, State, and Federal statutory and regulatory requirements.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Support Danaher Diagnostic Operating Company Medical and Scientific Affairs and Government Affairs organizations on their strategy so that it maximizes patient impact at scale. Prior roles in industry Medical and Scientific Affairs and/or Government Affairs functions a plus.
ExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: sr director Company: Govhr Usa
FEATURED BLOG POSTS
Why is Non-Verbal Communication Really Important?
In a world where words and phrases rule daily communication, you may wonder why non-verbal communication is important. Whether you realize it or not, you communicate more with nonverbal actions than you do with verbal communication. When you interact with your peers, people are reading your body language, facial expressions, voice, and many other factors that help fill in blanks that words can't fill.
Making Hybrid Work More Efficient
Covid was a catalyst for change in the work environment. Keeping people safe and helathy was the initial goal for employers, but the unintended result was the considerable demand in remote work. Now, onsite work has been dramatically altered to remote work, which is now transforming into a combination of the two: hybrid work.
How Can HR Technology Help Retain Employees?
Human resources' rapid adoption of technology has led to new ways of streamlining human capital management. Based on the IEE Global Study, these technologies changed how HR handled recruitment and retention in 2022. This includes tech like
Why is Time Management Important? 10 Crucial Importances of Time Management
We’ve all been there before. What starts as a relaxing evening scroll quickly becomes a full-blown binge. You blink, and it’s midnight - throwing off your entire next day before it even starts. And at its worst, this indulgence might leave you feeling behind on things you planned to finish that night. This is why time management is important.
Minimizing Candidate Renegs During the Hiring and Onboarding Process
Candidates reneging on job offers or during the onboarding process can be a frustrating experience for any recruiter. In a talent-driven job market, it’s common for candidates to have more than one job offer to consider. It becomes a race against time to see which organization can offer the best career experience, compensation, and circumstances that secure the right employees.
10 Reasons to Be on Time at Work
Being punctual at work may not be something you’ve given much thought to, but it’s the foundation for building a successful career. All of your technical or job-specific skills will be in vain if your peers and superiors can’t trust you to show up on time and do the work. In fact, Simon Sinek once famously said that
10 Importancies of Setting Realistic Goals
We’ve all heard how important it is to set professional and personal goals. Developing and establishing goals keeps us motivated and moving forward in life. But not all goals are created equal. If you’re chasing goals that are too lofty, you’ll end up disappointed when you cannot reach them. Setting goals that are achievable and measurable is the key to success.