The Associate Director, Regulatory Affairs CMC will be responsible for leading global regulatory CMC strategy for product development and registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) according to global regulatory expectations and requirements. This position works cross functionally with Regulatory Af

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out of the box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enable

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovativ

One of the nation’s largest independent testing facilities seeks an Analytical Chemist with a minimum 2 years experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Responsible for performing physical, chem

Primary Work Address NYU Medical Center, New York, NY, 10016 6481 Current HHMI Employees, click here to apply via your Workday account. The Littman laboratory at New York University is seeking a dynamic, driven, and curious Research Technician to join our group. The Littman lab investigates how T lymphocytes acquire functional properties during development and in response

Pharmacist Per Diem Facility St. Clare's Denville Location US NJ Denville ID 2024 154390 Category Clinical Professional Position Type Per Diem Shift Variable Job Type Non Exempt Overview At Saint Clare's Health, our dedicated team of professionals is committed to our core values of quality, compassion, and community. As a member of Prime Healthcare, Saint Clare's Health i

This position is responsible to implement and manage the company's regulatory affairs function. Oversee and manage ongoing relationships with regulatory authorities. Responsibilities include the development, implementation and management of the Company's compliance functions. Responsible to ensure general compliance with Federal, and State regulations applicable to the di

Shop floor oversight o Supports QA Operations programs especially related to batch release activities and shop floor programs which includes Visual Monitoring on Surprise, GEMBA walkthrough program, equipment/area/utility out of service program, QA area release of classified and unclassified areas, QA media fill oversight programs, event triage and support of routine oper

Job Type Full Time. Base Hours 8 30AM – 5 00PM Monday through Friday MINIMUM QUALIFICATION REQUIREMENTS To perform this job, an individual must be able to perform each essential duty satisfactorily, and meet the educational and experience requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES Microbial Limits testing and validation Preservative Efficacy testing Water t

This role is a strategic partner, a technical expert, an innovative problem solver and client presenter who can collaborate and design systems to solve these problems for new and existing clients alike. The Group Director, Transformation will be part of Initiative Management team responsible for data, martech & adtech integration and the future state of the industry acros

Responsible for managing all pharmaceutical activities including the purchase, inventory, control, and record keeping of all Drug Enforcement Administration (DEA) controlled substances stored in the pharmacy. Responsible for securing and maintaining a current facility DEA Registration Number and maintaining necessary legal records on controlled substance items. Provides t

Tris Pharma, Inc. (www.trispharma.com) is a leading privately owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our

MARS Solutions Group is looking for a Clinical Pharmacist in White Plains, NY Job Description Under the general supervision of the Director of Pharmacy Services the Clinical Pharmacist will assume the responsibility and accountability for the management of rational antibiotic therapy used within White Plains Hospital, or management of the critical care or high risk patien

You are an expert facilitator you open doors, foster communication, and bridge the gap. In this role, you will operate as the subject matter expert on reimbursement, access, and coverage issues affecting the clients product. Educate HCPs and their staff on matters related to reimbursement, access and coverage to facilitate appropriate patient access. You will Analyze acce

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer/Specialist to join our talented team at our office located in Somerset, New Jersey . In this role, you will perform cGMP compliance based services (commissioning, qualificat