- Cardinal Health (Sacramento, CA)
- …Review Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + Product Lifecycle ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- AbbVie (San Francisco, CA)
- …the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements. Must ... with Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory , HEOR and other functional areas, provides leadership, oversight, and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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
- Kelly Services (Burbank, CA)
- …a 4 to 8-week project. If you have experience in microbial testing and regulatory compliance in pharmaceutical , cosmetic, or nutritional industries, trust ... and various microbiological assessments. + Support documentation, reporting, and regulatory compliance initiatives. + Assist in cross-functional collaboration… more
- Grifols Shared Services North America, Inc (Bakersfield, CA)
- …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
- AbbVie (South San Francisco, CA)
- …years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (eg, other R&D role or specialized training). ... global regulatory strategies. + Preferred Experience: 10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory … more
- Abbott (Alameda, CA)
- …with outside regulatory agencies and trade associations, develop innovative regulatory compliance strategy, and provide executive management with ... regulatory submission. . Write and edit technical documents. . Administer/meet regulatory requirements to achieve excellent compliance status with no… more
- Eurofins (Davis, CA)
- …responsible for the implementation and oversight of Gold Standard Diagnostics' Regulatory System, to improve compliance and operational efficiencies. Essential ... Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and… more
- Abbott (Alameda, CA)
- …regulatory submission. + Write and edit technical documents. + Administer/meet regulatory requirements to achieve excellent compliance status with no ... life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical , in vitro diagnostic devices and/or… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …* Review and approve labels, labeling, and promotional materials to ensure regulatory compliance . * Work closely and collaboratively with Marketing and ... Directive, EU Electromagnetic Compatibility Directive, etc.). * Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more
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