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regulatory affairs in San Francisco Bay Area

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  1. (Senior) Associate Manager CMC Regulatory – Full Time

    DESCRIPTION: Responsible for supporting the CMC regulatory strategy and coordinating the process for compiling CMC section of regulatory submissions. Reviews CMC documentation to ensures they meet regulatory requirements. Coordinates CMC regulatory  workflow between departments as well as CROs Coordinates and compiles CMC document packages and investigational drug shipment related activities for drug manufacturing according to regulations/guidelines and company SOPs Assembles, coordinates and ...

  2. Associate Director of Regulatory Affairs

    The Associate Director of Regulatory Affairs reports directly to the Executive Director, Regulatory Affairs. This position coordinates departmental planning, manages multiple project teams and provides the regulatory strategies to ensure appropriate implementation of key business initiatives. This position is responsible for managing submissions to FDA and other regulatory authorities for investigational and marketed products.  RESPONSIBILITIES:    Contribute to the development, review, ...

  3. 94462 Global Regulatory Integration Specialist (12 months)

    Minimum Requirements: Skills: Proficient with Microsoft Office software Excellent verbal and written communication skills Strong organizational skills Excellent project execution skills with an ability to multitask   Organizational Skills: Can effectively and efficiently organize Regulatory Affairs and Labeling Development documentation to ensure accurate filing and timely retrieval of documents, can multi-task workload to ensure tasks are completed in a timely manner, knowledge of ...

  4. Director, Regulatory Affairs, CMC – Full Time

      DESCRIPTION: Responsible for ensuring the CMC regulatory strategy is in alignment with the global regulatory strategy and leading and coordinating the  process for compiling the CMC section of regulatory submissions. Work with cross-functional project teams to develop CMC regulatory strategy and ensure success of regulatory filings. Reviews CMC documentation to ensures they meet regulatory requirements. Represents RA CMC  at project team meetings and coordinates regulatory  workflow between ...

  5. Director Drug Safety Science (perm)

    Looking for strong Safety Surveillance experience, must have management experience as this position will manage other staff.   Minimum REQUIREMENTS: Pharm.D., Ph.D. or M.D. Minimum of 7-10 years experience with pharmacovigilance or clinical drug safety including risk/benefit analysis and safety assessment Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Must have excellent writing and communication skills ...