- Aldevron (Miami, FL)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... with regulatory requirements and company branding.In this role, you will...of the job include:5+ years of relevant experience in drug product label/labeling required,Experience with labeling equipment qualification and… more
- Aldevron (Miami, FL)
- …Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic ... as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality AgreementsDevelop and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …federal environmental regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, ... Device Regulation (IVDR) as well as all other applicable global regulatory requirements.Maintain oversight, tracking, metric reporting and escalation of issues while… more
- Cytiva (Miami, FL)
- …as related to compliance with internal and external quality and regulatory standards. Assist with the implementation of standard operating procedures to ... to establish and maintain document controls that align with applicable regulatory requirements. Ensure compliance with documentation requirements defined in ISO… more
- Stryker (Cary, IL)
- …Sciences, Chemistry, or a related field Minimum of 10 years of experience in drug regulatory affairs. + Experience interacting with regulatory agencies. ... Specialist,** you will play a pivotal role in shaping and executing global regulatory strategies for drug development and lifecycle management. This position… more
- Teva Pharmaceuticals (West Chester, PA)
- …5% international travel required. **Your experience and qualifications** Bachelor's degree in Drug Regulatory Affairs, Pharmacy, Biology, Chemistry, or a related ... or Batch Records + Regulatory Reporting Requirements, Regulatory Assessments and Impact on Implementation + Drug... Regulatory Assessments and Impact on Implementation + Drug , Biologic, or Biosimilar Development + SOP Training and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Affairs, Precision Medicine, you will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory ... as applicable. You will provide fit-for-purpose operational and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs,… more
- Ascendis Pharma (Princeton, NJ)
- …Senior Management and cross-functional partners to provide portfolio or therapeutic level regulatory insight and broader drug development expertise. + Actively ... a regulatory agencies + Experience with biologics, CMC, Toxicology, regulatory incentives, such as Orphan Drug Designation, breakthrough designation, fast… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Utlizes profound GRA CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to address and overcome challenges ... Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and… more
- Lilly (Indianapolis, IN)
- …effecting change in regulatory policies that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of ... which will center around topics that encourage innovation in drug development and regulatory review of genetic and neuroscience medicines + Critically review… more
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