Senior Director, CMC Regulatory Affairs job in San Diego, CA - Pharmaceutical Associates

• Senior Director, CMC Regulatory Affairs

  Pharmaceutical Associates - San Diego, CA

  Position Responsibilities : Prepare information necessary for investigational, marketing, and/or post-licensure regulatory submissions (including INDs, IND amendments, IND/NDA annual reports, BLA/NDAs, BLA/NDA/CMC supplements, etc.) in accordance with the regulations and relevant guidelines (domestic, national and international). Prepare CMC portion of the IND and NDA in CTD format. Prepare labeling with full prescribing information. Develop and maintain quality assurance structure for regulatory submissions in accordance with overall quality structure. Responsible and accountable for participation on multiple products and project teams. Prepare, and/or review and approve routine regulatory submissions, including annual reports, periodic safety reports, and expedited safety reports, as necessary... See job listing >

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Senior Director Cmc jobs in San Diego, CA

• Senior Director, CMC Regulatory Affairs

  Pharmaceutical Clinical Associates - San Diego, CA

  IND/NDA annual reports, BLA/NDAs, BLA/NDA/CMC supplements, etc.) in accordance with ... Prepare CMC portion of the IND and NDA in CTD format...

  30+ days ago from Pharmaceutical Clinical Associates, LLC - Save - More Tools...
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• Manager/Sr. Manager, Quality Systems

  Nexbio - San Diego, CA

  Assurance program. Reporting to the Senior Director of Corporate Quality Operations, ... corporate GXP training programs Audit CMC and clinical trial documents for...

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Pharmaceutical Associates jobs

• Sr. Clinical Quality Specialist

  Pharmaceutical Associates - Rochester, NY

  Support the Global Clinical Programs Clinical Quality and Document Control function with a primary responsibility for conducting internal and external audits. Job Duties: Conduct

  21 days ago from Pharmaceutical Associates,LLC - Save - More Tools...
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• SR Clinical Data Coordinator

  Pharmaceutical Associates - Raritan, NJ

  clinical data management experience in a pharmaceutical or Biotech Company or CRO. A. Essential Functions: Provide leadership for all data management activities to ensure database...

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• Regional Clinical Research Associate

  Pharmaceutical Associates - New Jersey

  Responsibilities include: *Performing site visits to monitor and ensure study/protocol compliance according to GCPs/ICH, and other regulatory agency guidelines; *Ensuring that the

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• Oncology Clinical Program Manager

  Pharmaceutical Associates - Boulder, CO

  or life science environment in the pharmaceutical industry or clinical research organization. Clinical research experience in phase I - III oncology clinical trials (as listed...

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