- TestPros (MD)
- …better, safer and more secure. Job Summary TestPros is seeking a Project manager with Section 508 experience for a Federal contract. Position: Full-time Citizenship: ... within a single organization or serves as the project manager of a single large program containing multiple task...Document that the documents fully passes the HHS and FDA checklists. Notify the PM when a document requires… more
- The Clorox Company (Alpharetta, GA)
- …Regulatory Team to identify and manage non-tariff barriers such as EPA and FDA requirements for imports/exports. + Other GTC Regional Leaders for cross-border trade ... & Anti-boycott; Identifying and managing non-tariff barriers ( _e.g.,_ EPA, FDA import/export regulatory matters); Import/export laws and regulations in countries… more
- BeOne Medicines (Pennington, NJ)
- …and release of materials, intermediates, and finished products under FDA /EU regulations, applicable international regulations, and BeOne processes and procedures. ... Bachelor of Science degree and 5+ years of experience in an FDA -regulated biotechnology, pharmaceutical company with progressive levels of responsibility required. +… more
- Insight Global (Beachwood, OH)
- …analysis plans and protocol review cycles. o Submit and manage regulatory applications ( FDA and other global agencies). - Clinical Execution & Oversight o Oversee ... clinical trial design, including randomized controlled trials and regulatory standards ( FDA , IRB). . Strong leadership, communication, and interpersonal skills with… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... English; additional language skills are a plus. Preferred Skills: + Experience with FDA , EMA, or other regulatory inspections. + Familiarity with software tools used… more
- Lilly (Indianapolis, IN)
- …: Ensure that all systems and equipment meet **GMP and regulatory standards** ( FDA , EMA, etc.) from design through validation + **Support for IT system integration ... Engineering or Science related degree. + 5+ years' experience working in an FDA regulated operation including at least 2-3 years' experience in CQV **Additional… more
- ThermoFisher Scientific (Mount Prospect, IL)
- …+ Manage and elevate the site Quality System to align with cGMP, FDA , EMA, and global regulatory standards, ensuring adherence throughout all packaging, labeling, ... or distribution is required. + Regulatory Expertise: Extensive understanding of cGMP, FDA , EMA, and other global regulatory requirements, with a track record of… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …understanding of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory ... etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for… more
- US Tech Solutions (San Bruno, CA)
- …and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory audits. + Performing product qualification ... of work. + Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + Experience working with products incorporating hardware, firmware and… more
- United Therapeutics (Silver Spring, MD)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... while also serving as a people leader. The Tax Manager is responsible for supporting a wide array of...assets and other projects, as assigned. + The Tax Manager role encompasses the following essential duties & responsibilities… more
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