- Daiichi Sankyo, Inc. (Bernards, NJ)
- …redesign and SOP authoring/coordination (Required)3 or more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of… more
- Merck & Co. (Rahway, NJ)
- …Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- The Pharmacy Hub (Miami Gardens, FL)
- …is preferred. *Demonstrated understanding of GMP, FDA, OSHA, and other regulatory guidelines relevant to pharmaceutical production. *Strong project management ... About Us At The Pharmacy Hub , we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver… more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …5+ years or Master's/ Bachelor's with minimum 8+ years relevant experience in pharmaceutical regulatory affairs. Minimum of 5 years of experience (preferably ... of Post-Marketing is responsible for providing management of a post-marketing regulatory activities, ensuring compliance with regulatory requirements, and… more
- Katalyst HealthCares and Life Sciences (Irvine, CA)
- …biochemistry or similar science related field preferred. Minimum 5 years of pharmaceutical regulatory or regulated content management (eg, labeling, or Company ... Responsibilities: The Regulatory Affairs Manager is responsible and accountable for...and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.… more
- Merck & Co. (Upper Gwynedd, PA)
- … Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... and Skills: At least five (5) years of relevant experience, including biological/ pharmaceutical research; manufacturing, testing, or regulatory CMC; or related… more
- Eisai, Inc (Nutley, NJ)
- …relations, government price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and ... standing of a state bar. Strong knowledge of FDA regulatory and fraud and abuse laws and/or pharmaceutical... regulatory and fraud and abuse laws and/or pharmaceutical government price reporting laws. Ability to learn quickly… more
- Eisai, Inc (Nutley, NJ)
- …orientation to identify breakthrough opportunities.Comprehensive understanding of legal and regulatory issues impacting pharmaceutical product marketing as well ... 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise in Lean ... entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize… more
- Eisai, Inc (Nutley, NJ)
- …of brand plansStrong communication and presentation skillsUnderstanding of legal and regulatory issues impacting pharmaceutical product marketing as well as ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience and 4+ ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Cedent (Boston, MA)
- …4. What We're Looking For *Experience: A minimum of 10 years in regulatory affairs within the biotechnology or pharmaceutical industry, with direct involvement ... As a Clinical Trial Regulatory Affairs Specialist, you will be responsible for:...Regulatory Affairs Specialist, you will be responsible for: * Regulatory Compliance: Ensuring all clinical trials adhere to applicable… more
- Merck & Co. (Rahway, NJ)
- …Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause ... interface between our company and our External Partners (EP) for Active Pharmaceutical Ingredients (API) and intermediates. You will be responsible for providing… more
- Lundbeck (Raleigh, NC)
- …resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence ... policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Lundbeck (Edmond, OK)
- … Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Abbott (Pleasanton, CA)
- …and Health Hazard Assessments for on-market (distributed) product Medical device, regulatory environment or pharmaceutical manufacturing Credentials of a ... development. Perform Health Hazard Evaluations Works cross functionally with development/manufacturing/quality/ regulatory /clinical to establish product risk documentation. Demonstrates compliance with… more
- Olema Oncology (Boston, MA)
- …Experience: 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within ... longer. For more information, visit us at www.olema.com. About the Role Director, Regulatory Labeling As the Director, Regulatory Labeling, reporting to the Vice… more
- Travere Therapeutics (San Diego, CA)
- …and BLAs. *Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production. *Review project scope and ... external CDMOs and collaborating closely with colleagues in Technical Operations, Quality, Regulatory CMC, and Supply Chain. This position is a key CMC contributor… more
- Phlow Corp (Petersburg, VA)
- …schematics, and technical manuals. Knowledge of GMP, OSHA, and other regulatory requirements in a pharmaceutical environment. Familiarity with computerized ... are seeking a highly skilled and experienced Automation Engineer to join our pharmaceutical manufacturing plant and help create the future of how medicines are made… more
- Cipla (Fall River, MA)
- …work instructions and document results. Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment highly preferred. ... is to assist in the warehouse operations of a pharmaceutical manufacturing company. Scope : The scope (content and...online documentation & area as per cGMP guidelines and regulatory requirements to avoid any deviation. Review the status… more
Related Job Searches:
Director Regulatory Pharmaceutical,
Pharmaceutical,
Pharmaceutical Regulatory Compliance,
Pharmaceutical Regulatory Compliance Manager,
Pharmaceutical Regulatory Operations,
Pharmaceutical Regulatory Quality Manager,
Regulatory,
Regulatory Affairs Pharmaceutical,
Regulatory Strategy Pharmaceutical