- UpvoteDownvoteShare Job
- Suggest Revision
The QA Associate provides support to Indianapolis API Operations (Active Pharmaceutical Ingredient) manufacturing and laboratories and ensures quality systems and GMP compliance. Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Demonstrate a working knowledge of US regulatory guidelines including FDA product promotional guidance, PHRMA Guidance and OIG, Guidance for pharmaceutical manufacturers. Director, US Medical Affairs Excellence Psychiatry will serve as the external engagements, insights, and scientific communications & training lead for the Psychiatry Medical Affairs therapeutic area.
RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
These activities will be performed in cross-functional collaboration with a range of partners throughout the organization, including the US Market Access, US Medical Affairs, Medical Outcomes Science Liaison (MOSL), Public Policy & Government Relations, and US Regulatory Affairs teams.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The position will rely on the ability to create, lead and work within cross-functional teams made of participants from U.S. Commercial Analytics & Operations, including Commercial Excellence, Marketing Analytics & Business Insights, Customer Experience, In-Field Team Effectiveness, Patient Services; U.S. Commercial Marketing, Market Access Marketing, Medical Affairs, Regulatory, Legal, Office of Ethics & Compliance, HEOR, Agency Relations, Business HR, and other internal/external partners.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Works to ensure Eisai's compliance with pharmaceutical laws including the Anti-Kickback Statute, False Claims Act, PhRMA Code and FDA regulatory guidelines. The successful candidate will be primarily responsible for providing counsel specific to Eisai's pharmaceutical regulatory needs, including sales and marketing, scientific exchange and other medical activities, monitoring, co-promotions, and FDA standards for a variety of pipeline and in-line assets.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
As a Regulatory Affairs Associate, you will be responsible for managing the day-to-day chemistry, manufacturing, controls (CMC) regulatory activities for all assigned marketed products.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. The Associate Director, Global Medical Affairs will provide medical leadership for medical affairs strategy, planning and supportive tactics for Oncology.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Bachelor’s degree required; preferably in marketing or communications to support content development that effectively reflects challenges in the pharmaceutical industry. 3-5 years of pharmaceutical industry experience.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. The Associate Director, Regulatory Affairs will be accountable for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Experience working cross functionally with greater CMC/Technical Operations team, Quality Assurance and Regulatory Affairs. Author relevant pharmaceutical and manufacturing development sections of clinical and commercial regulatory filings.
$194,000 - $237,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
A minimum of 3 years of Regulatory Affairs experience with focus on the North America region and FDA is required. Provide regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Ensure that regulatory strategies also consider non-regulatory market access issues (e.g., health technology assessments, payor demands). At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. Solid understanding of Worldwide Health Authority laws (with a focus on FDA), regulations, guidances, and regulatory submission routes available for new study drugs is required.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent and unified regional regulatory strategies. Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist.
ExpandApply NowActive JobUpdated Yesterday
regulatory affairs associate pharmaceutical jobs
FEATURED BLOG POSTS
How to Decide Between Two Job Offers: 10 Practical Tips
It’s arguably a good predicament to have. You’ve applied to many jobs, interviewed multiple times, and now find yourself with two legit job offers. Nice! But although this is a feel-good validation of everything you have to offer, a daunting choice lies ahead. How do you decide which job will be the best fit for you?
Why Work in Sales? 9 Reasons & Tips on Answering as an Interview Question!
Working in sales can be demanding and challenging, but it can also be gratifying. Sales is an excellent career with a clear path full of excitement and potential for growth. So, if you're contemplating careers and have wondered "why work in sales?", keep reading to determine if sales is a suitable role for you.
How to Fire an Employee
So… you've finally decided to let one of your employees go. Drafting the paperwork and corresponding with HR is the easy part, but knowing how to fire an employee is where things get complicated. In fact, it is one of the most challenging conversations to have in the workplace. However, it must be done, and it must be done with poise and tact. Not only should you keep your state law in mind, but you should also consider your former employee's wellbeing.
How Long Does it Take to Hear Back from a Job?
Are you applying for your very first job? Maybe you’re anticipating your termination from your current role and want to be proactive. Either way, waiting to hear back on your job application can be stressful. If time has passed since you applied, you may wonder how long does it take to hear back from a job. Well, the answer is... it depends.
How to Respond to a Recruiter Through Email? (Tips & Examples)
Rather than wading through an endless list of open roles, wouldn’t it be nice if relevant job opportunities come to you?
How to Reject a Candidate Professionally
When deciding on how to reject a candidate, your first question may be
How Does Salary Pay Work? (Compared to Hourly Pay)
At the bottom of each job advertisement, companies label a role as salaried or hourly. Both methods will get you paid (yay), but each in very different ways. So, it's essential to figure out how does salary pay work? While employees paid by the hour are paid based on how long they work, employers pay salaried employees a fixed amount.