- UpvoteDownvoteShare Job
- Suggest Revision
Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Senior Director of Regulatory Affairs and Strategy will develop and implement comprehensive regulatory strategies and oversee daily regulatory affairs activities, including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance to support the successful development, approval, and marketing of Marengo products.
ExpandApply 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.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. 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
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
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 Today - UpvoteDownvoteShare Job
- Suggest Revision
Under the direction of the Senior Director, this position collaborates and regularly meets with key stakeholders, including Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
This role functions in a matrix team environment, interacting with several key stakeholder groups including Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research, and Legal.
ExpandApply NowActive JobUpdated Today - 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
Drive awareness among Pfizer senior leaders of the value created / ROI from oncology development-focused AI/digital technological innovation, and work with Oncology Scientific Affairs and Strategic Partnerships colleagues on external communications on these topics.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Regularly briefs Academic Affairs, Director of PAL, Residential Life, Student Affairs, Office of Disability Services (ODS), and Counseling Center on social learning issues; Under the direction of the Division of Academic Affairs, the Speech Language Pathologist (SLP) / SAIL Program Coordinator will facilitate programs and activities for students and families enrolled in our Social Assistance in Learning (SAIL) Program.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Act as a liaison between cross-functional teams, including clinical operations, regulatory affairs, finance, and business development, fostering strong communication and collaboration throughout the contract lifecycle.
ExpandApply NowActive JobUpdated Yesterday - 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 - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Director, Medical Affairs will be a leadership role, accountable for Medical Affairs strategy, Medical Excellence, and field team execution for Orchard's investigational and approved hematopoietic stem cell - gene therapy (HSC-GT) clinical programs in North America (NA.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Cross-Functional Collaboration:Collaborate closely with clinical development, translational medicine, biostatistics, regulatory affairs, and external collaborators to integrate biomarker strategies into clinical programs.
Full-timeExpandApply NowActive JobUpdated 3 days ago
regulatory affairs jobs Title: sr director Company: Govhr Usa in Boston, MA
FEATURED BLOG POSTS
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.
Internship Cover Letter Tips with Examples
Until now, college has been about learning, absorbing, and experiencing. It’s not until you become eligible for an internship that things start getting real—real-world experiences using real-life scenarios. Applying for internships takes time, and there’s no college course on “how to apply for jobs.” (We’d sign up immediately if there was, though!) But here's a spoiler alert: most internships require a cover letter. And while this may seem like a burden, it’s actually a blessing.
5 Practical Ways to Remove Bias from your Hiring Process
Many employers think their hiring process is perfect. However, research shows that the hiring processes are generally impartial and unfair, especially if you are part of certain demographics. Women, people of color, people with disabilities, or even people in lower socioeconomic status are more likely to be subject to implicit bias. As diversity and employer branding become major aspects of business, it is important that employers take the lead to identify and remove bias from the hiring process. So, here are 5 practical ways to get you started.
Tips to Get Your First Job Confidently
Whether you’re a recent graduate or you still have a few exams left, you may be itching to put your polished leather shoes on and join the workforce. After all, your first job is an entryway into the professional life you’d lead for the decades to come.
Tips for a Good Character Reference Letter with Examples
Hiring managers love a resume laden with relevant skills and qualifications. Hard skills specific to the role, like SEO strategy or Java programming languages, are easy to qualify using achievements or facts and figures. But how exactly can they verify personality traits, work ethic, relationship management skills, or curious nature during an interview when they barely know you?