- UpvoteDownvoteShare Job
- Suggest Revision
The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Regulatory Affairs Manager also develops and maintains familiarity with key health plan operational processes to inform our advocacy efforts. The Senior Regulatory Affairs Manager, in collaboration with the Director, LRAC, will lead the federal advocacy efforts through trade associations, including America's Health Insurance Plans (AHIP.
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.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Minimum of 5+ years of experience in a Regulatory Affairs for medical devices and drug-device combination products.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Ipsen clinical study team members (TA, Biometry, Pharmacovigilance, Finance controlling, Global Regulatory Affairs, CMC Supply chain.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Work closely with NGS production, Quality and PreClinical Genotox for compliant execution of genotoxicity data packages in support of regulatory filings and clinical programs. Interact with Health Authorities, in writing and verbally, including pre-submission (e.g., pre-IND), scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
ASSISTANT VICE PRESIDENT, FINANCE AND ADMINISTRATION, External Affairs Tracking Code Job Description Boston University External Affairs is actively seeking an Assistant Vice President, a pivotal role that will provide strategic direction and leadership in human resources, finance, administration, and operations.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Director, Model Validation for SHUSA 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
At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Qualifications·Demonstratedcapacityforsound legal analysis, legal reasoning, problemsolving,and legalresearch and writingskills;·Experience with administrative law, government/legislative affairs, and/or litigation;·An even temperament, principled judgment, and a positive outlook;·Strong oral and written communication skills;·Experience with Relativity eDiscovery platform a plus.
$74,818 - $109,718 a weekFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Responsible for developing, executing, and publishing outcomes research following Takeda policies and in cooperation with the US Medical Affairs Team. You will be part of US Medical Affairs and is responsible for developing and executing health economics and outcomes research for assets across multiple therapeutic areas and multiple timepoints of development.
$169,400 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
Full-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: regulatory specialist Company: Abbvie in Cambridge, MA
FEATURED BLOG POSTS
What is a Policy of Non-Retaliation & How to Create One
Your company probably has many policies in place – anti-discrimination policies, equal opportunity policies, ethics policies, and so on. However, it is important to re-evaluate whether you have a policy that covers every situation. Say for instance one of your employees submit a complaint in good faith to their supervisor. To their surprise, they are met with retaliation, such as demotion, defamation, or even termination.
How to Take Your Careers Page to the Next Level
Your careers page deserves a lot of attention. It is not just another page on your website. It is a vital tool that could enhance your recruitment outcomes. But in order to do that, you have to make sure it's fully optimized.
When to Tell Your Boss You're Job Searching
The Bureau of Labor Statistics has found that individuals, on average, have 12.4 jobs throughout their working life. So regardless of where you are on the career ladder, it’s inevitable that at some point, you’ll begin looking for another job. That said, you might be wondering,
What Questions Can You Not Ask in an Interview?
It can be stressful to interview candidates to fill an open role at your company. Maybe your boss is on you to hire someone who’s absolutely perfect as soon as possible. Maybe you don’t have a ton of experience yet in conducting interviews. Whatever the case, there’s a lot to take under consideration when you’re the one in charge of interviewing. For instance, “What questions can you not ask in an interview?” may very well be running through your mind given its legal ramifications. Knowing exactly which interview questions are off-limits (and which are fine to ask) will boost your confidence as you continue to search for the ideal new hire.
How to Prepare to Be Fired - What You Need to Do
If you’re reading this, let me be the first to tell you how sorry I am. Getting fired feels crappy, disheartening, hurtful, and all the other bad, sad words. But here’s what I want you to do. First, let yourself fumble for a minute. Then, pick your head up — sometimes getting fired is a blessing in disguise. If you think termination is around the corner, we’ll teach you how to prepare to be fired and what to do next so you land somewhere even better.
How to Find a Job That Makes You Happy - 11 Concerning Facts
Do you ever feel like your life is like one of those rom-com movie scene openers? You know, the ones where the main character rolls out of bed, awakened by a casually upbeat theme song, sulks their way to the coffee pot, and then trudges toward their computer to begin yet another boring day at work?
How to Decline a Job Offer You Already Accepted
When you think about it, turning down a job offer is not the worst position you could be in. If you’ve been lucky enough to consider multiple job offers, well, then you’re lucky enough.