- Cytiva (Miami, FL)
- …responsible for providing quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading ... and product launches.This position reports to the QA Senior Manager Site Quality Leader and is part of the...Quality Leader and is part of the Quality and Regulatory Affairs Team located in Shrewsbury, MA. and will… more
- Katecho (Des Moines, IA)
- …a strong background in pharmaceutical manufacturing, quality control, and regulatory compliance . PRIMARY DUTIES AND RESPONSIBILITIES + Quality Management: ... Surmasis Pharmaceutical - Quality Manager (M -...FDA, EMA, ICH, and GMP. + Regulatory Compliance : Ensure compliance with applicable pharmaceutical… more
- Eurofins (Rensselaer, NY)
- …Minimum Qualifications: + Minimum of five years' experience in the pharmaceutical industry and/or FDA experience, Quality Assurance/ Compliance . + Experience ... is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is… more
- Catalent Pharma Solutions (Kansas City, MO)
- …Associate Pharmaceutical Technician. At the direction of the Zone Operations Manager or Pharmaceutical Manufacturing Lead, the Associate Pharmaceutical ... **Associate Pharmaceutical Technician** **Position Summary** Catalent, Inc. is a...adhering to policies and procedures with an emphasis on regulatory related processes such as SOPs, cGMP and safety… more
- PCI Pharma Services (Bedford, NH)
- …the agreed quality compliance targets for the site, supporting client and regulatory audits as required. + To be responsible for the selection, training and ... network to pioneer and shape the future of PCI. **Director, Pharmaceutical Development - Sterile Drug Product** **Location: Bedford, NH** **Position Overview:**… more
- Turner & Townsend (Marietta, PA)
- …across all stakeholders, ensuring transparency and owner oversight. Ensure compliance with contractual obligations, regulatory requirements, and organizational ... Description** **Turner & Townsend** are seeking an ambitious construction **Senior Change Manager ** to join our growing Life Science team. The ideal candidate is… more
- NTT America, Inc. (NY)
- …processes. Practice specialties include preclinical discovery, clinical trials, regulatory quality and compliance , medical affairs, pharmacovigilance, ... Sciences clients: https://us.nttdata.com/en/services/consulting-services/life-sciences-consulting **How You'll Help Us:** As a Pharmaceutical Manufacturing Intelligence Consulting Manager , you will… more
- Fresenius Medical Center (Knoxville, TN)
- …of a medium-sized company + Supporting the department in cross-site activities to monitor product quality and regulatory compliance **EOE, disability/veterans** ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …assigned project teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary ... all CMC and GMP related documents for submission to regulatory authorities to assure compliance with ...programs (Word, Excel, PowerPoint, and Outlook). + 7-years CMC regulatory experience in the pharmaceutical industry with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required) + 2 or more ... as other research areas centered around rare diseases and immune disorders **Job Summary:** The Regulatory Process Manager will be a key member of the Global … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …ICH guidelines; + cGMP standards; + Federal and State laws related to pharmaceutical regulatory affairs; + Business, scientific and personal computer software ... * Manager , Regulatory Affairs Date: May 1,...test methods, etc. + Implement policies to assure on-going compliance of Regulatory Affairs activities. + Assess… more
- Charles River Laboratories (Charleston, SC)
- …Certification in regulatory compliance or related fields (eg, CRCM, Certified Regulatory Compliance Manager ) is a plus. + Familiarity with Global ... passionate about. **Job Summary** We are seeking a detail-oriented and knowledgeable Regulatory Compliance Engineer to ensure our products, processes, and… more
- Bausch Health (Bothell, WA)
- …all inclusive of the duties and responsibilities for this position title._ The Manager Regulatory Affairs provides direct support to Solta operations for their ... Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive...Management and Reporting** + Conduct risk assessments related to regulatory compliance , helping the company identify potential… more
- Teva Pharmaceuticals (West Chester, PA)
- …or a department that works closely with RA including Quality Assurance, Regulatory Compliance , Regulatory Operations, Quality Control, Program Management, ... * Manager , Regulatory Affairs Date: May 5,...a Master's degree in the specified fields. Must have biotech/ pharmaceutical industry experience with: + GXP including cGMP practices… more
- Takeda Pharmaceuticals (Boston, MA)
- …ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance ; Assist the Global Regulatory Lead with Health ... the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs, Marketed Products **POSITION DESCRIPTION** :… more
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral ... Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write… more
- J&J Family of Companies (Raritan, NJ)
- …licensing, or divestiture of assets, products or businesses. This role ensures regulatory compliance and alignment with applicable global health authority ... We are searching for the best talent for a ** Regulatory Affairs Manager , Special Projects (Acquisition &...Legal, Finance, Quality, Clinical, Deliver, Supply Chain, GSM/Commercial, Trade Compliance , EHS, and IT in support of A&D projects.… more
- AbbVie (San Francisco, CA)
- …R&D, or Industry-related experience. + Preferred Experience: 2-3 years in pharmaceutical regulatory activities + Demonstrates excellent negotiation skills, ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy, US & Canada position is… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role ... Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations,...and assessments, as well as task management to ensure compliance with quality management systems + CMC regulatory… more
- Lilly (Philadelphia, PA)
- …solutions to support communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the preparation ... and delivery of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally.… more
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