- UpvoteDownvoteShare Job
- Suggest Revision
Johnson & Johnson is recruiting for a Principal Scientist, CMC Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; Malvern, PA or Spring House, PA. The Principal Scientist, CMC Regulatory Affairs provides support for the registration activities for a diverse portfolio of biologic drug products.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies. Perform other regulatory tasks as assigned. Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Manager, Regulatory Affairs: Base Salary Range $90,000 - $120,000. Onboard and conduct Veeva system and standard operating procedure (SOP) training for Internal and External parties. Ensure all promotional materials are properly vetted through the review process utilizing the cloud-based review system (Veeva PromoMats.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Medical & Scientific Affairs Lead - OTC provides expert medical and scientific support to multiple departments and interdepartmental teams including R&D cross functions, Innovation, Marketing /commercial, Clinical Development, Regulatory, Category, BU’s etc.
$297,238 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Advanced life science degree or certification in Regulatory Affairs Sciences preferred. Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
This individual will be responsible for delivering CMC documentation (Dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
- Suggest Revision
CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The position interfaces with experts in Process Development, Analytical Development, Manufacturing Sciences and Technology, Operations, Quality and Regulatory Sciences. Experience with regulatory documentum software (CARA, eSub, etc) is strongly preferred along with proficiency in compliance ready standards for final publication.
ExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Accountable for collaboration with cross-functional teams, including research and development, legal, regulatory affairs, and business development, to ensure IP considerations are integrated into product development and commercialization strategies.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
Partner with SME organizations to identify source documents and negotiate delivery of approved technical documents in accordance with project timelines and aligned with CTD requirements and regulatory strategy.
ExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
$142,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Create the clinical development strategy for one or more assets in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Scientific Director, US Medical Affairs, Endocrinology will serve as a scientific/medical expert to lead and manage strategic initiatives and projects that integrate Recordati’s scientific, clinical data into programs that drive business and medical affairs priorities.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
Strong experience in VEEVA, life-cycle tools & regulatory affairs. He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
ExpandApply NowActive JobUpdated 1 month ago
regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Somerville, NJ
FEATURED BLOG POSTS
In-House vs Outsourcing Recruiting: Which is Better?
When looking at in-house vs outsourcing recruiting, it is important to nail down the benefits for each and whether those benefits outweigh the risks that follow.
How to Write a Short Bio
First impressions can be tricky. When meeting someone in person, it’s likely you have an elevator speech. These short, practiced introductions can help you share more about who you are, what you do for work and other facts about you. While this works well in a live, in-person context, there are many cases where professionals “meet” someone via written form - like social media, a resume, or published work. In these cases, your bio works as your first impression. So, here’s a step-by-step guide on how to write a short bio.
How to Conduct a Performance Review (With Examples)
In a world where the smallest mistake can cost your business tens of thousands in lost revenue, your talent is key to keeping your edge on the market and driving growth. However, managing a workforce of any size can be a challenge. Employees come with their own particular skill set, ambitions and flaws. So, it can be difficult to uncover their individual drivers. Not to mention the challenges brought on by the hybrid and remote working models where in-person interactions have become few and far between.
How to Recruit Passive Candidates
Learning to recruit passive candidates is a different ballgame than recruiting active ones. While an active candidate is someone who is currently looking for a new job, a passive candidate tends to be the opposite. Passive candidates are either already working or not looking to work. So, instead of these candidates coming to you, you'll have to find them and reach out to them first.
How to Effectively Recruit Employees
Today, hiring and retaining talent looks much different than it did only two or three years ago. Financial instability and the strain on our mental health brought on by the pandemic has made everyone more wary and selective of their workplace and employer. Whereas in the past people might have prioritized promotions and financial reward, today they look at other factors such as workplace flexibility, personal fulfillment and values alignment.
How Many Hours is Part-Time vs. Full-Time Work?
Growing up you watched your parents shuffle to and from the office, held hostage to their 9 to 5. If jammed-packed schedules and deadlines sound frightening, you might consider pivoting your search to part-time jobs. In fact, even employers have shifted their preference, selecting more people open to the idea of flexible working hours.
How to Make a Job Offer More Competitive
Money alone makes it hard to attract and retain top-notch candidates, especially when you are competing with larger businesses and corporations in your industry. So, instead of focusing on money, figure out how to make a job offer more competitive when you can't offer more money.