- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Merck & Co. (Rahway, NJ)
- …Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root ... matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in… more
- Eisai, Inc (Boston, MA)
- …decision-making within local markets and healthcare systems).Experience working with pharmaceutical manufacturer compliance & regulatory ... 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
- Eisai, Inc (Nutley, NJ)
- …training, marketing, managed markets, sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory ... 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)
- …with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in… more
- Inizio Engage (Long Beach, CA)
- …opportunities, track sales performance, and optimize territory management. Adhere to regulatory and compliance guidelines while maintaining ethical and ... to partner with Tonix Pharmaceuticals and are seeking a team of Pharmaceutical Field Sales Representatives who are performance-driven, proven, and ambitious sales… more
- PCI Pharma Services (Philadelphia, PA)
- … pharmaceutical , life sciences, or healthcare industry. Familiarity with pharmaceutical manufacturing operations and regulatory compliance requirements. ... complex data into actionable insights that support PCI's sustainability goals and regulatory requirements. This is a cross-functional role that requires a balance 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 ... Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… 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
- MMS Holdings Inc. (Canton, MI)
- … issues or projects. Author and maintain documentation as required to sustain regulatory compliance . Provide senior technical review for complex regulatory ... culture and industry best employee retention rate. We support the pharmaceutical , biotech, and medical device industries with our proven, scientific approach… more
- BioSpace (Tarrytown, NY)
- Job Details The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with ... (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying… 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...combination products. Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life… more
- Merck & Co. (Rahway, NJ)
- …Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance , Reviewing Literature {+ 4 more}-Preferred Skills:Job ... leading a team for a common goal-Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation… more
- Cedent (Boston, MA)
- …Trial Regulatory Affairs Specialist, you will be responsible for: * Regulatory Compliance : Ensuring all clinical trials adhere to applicable regulations ... external regulatory agency audits by providing necessary documentation and regulatory input to minimize potential findings of non- compliance . This role… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical,… more
- Loyola University Chicago (Chicago, IL)
- …Research Organizations and monitors for Study related management expectations and ensure regulatory compliance . Communicates with the local IRB to ensure all ... and Credential Repository (RCR). Participates in internal/external audits to ensure regulatory compliance and implement corrective and preventive action plans… 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,… more
- Cedent (Bastrop, TX)
- The Site Compliance Manager combines expertise in operations, training, and regulatory oversight to oversee regulatory compliance within our facility. ... Assist the General Manager with facility management to ensure cGMP and OSHA compliance . Provide oversight of incoming pharmaceutical products to ensure all H&S… more
- Merck & Co. (Rahway, NJ)
- …selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once ... Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS).- Education Minimum Requirements:- Bachelor's… more
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