Danielle Turner Email & Phone Number

San Diego, California, Us

San Diego, California, Us

• Lead the management of key regulatory activities, such as preparation of biologics license /marketing authorization applications, Japanese drug master files/new drug applications, Chinese drug master files, agency meeting requests and coordination of filing efforts between corporate disciplines• Develop and implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for projects (i.e. new working cell banks, new reference standards, dual sourcing, and shared manufacturing arrangements)• Liaise with partners and contract manufacturing organizations for support in addressing agency requests, foreign manufacturer accreditations, and dossier lifecycle • Review of partner’s investigator brochures, clinical protocols, and briefing books• Influence in a matrixed environment and hold direct reports and colleagues accountable to timelines, action items, and identifying and mitigating regulatory risks• Develop a short term and long term process for regulatory document lifecycle management, including version control, archiving, and reviewing

Network Strategy - Plasma Team Lead• Provide global regulatory strategy for major changes to the supply network, such as:o Changes to external networko Internalizationo Site to site transferso Major QC transfers• Participate as an active team member and provide regulatory advice to cross-functional project teams• Ensure project teams and business objectives and deliverables are aligned with regulatory strategy • Maintain Chemistry, Manufacturing, and Controls (CMC) regulatory files in a format consistent with eCTD requirements• Manage a staff across multiple geographic locations

Tokyo, Jp, Jp

• Responsible for the implementation of regulatory strategies• Provide guidance and coaching for improvement of the change control process• Provide Regulatory advice and manage Regulatory activities relating to Change Control • Provide feedback and evaluate the impact of a proposed change.• Obtain and maintain marketing authorizations for product(s) and communicate general regulatory requirements in support of licensing of Baxter’s products.• Compile and submit regulatory documents according to regulatory requirements • Participate as an active team member and provide regulatory advice to cross-functional project teams, as required • Ensure project teams and business objectives and deliverables are aligned with regulatory strategy • Maintain Chemistry, Manufacturing, and Controls (CMC) regulatory files in a format consistent with eCTD requirements

Deerfield, Illinois, Us

• Core Team Member (Validation Representative) for top facility projects, including autoclave load configuration optimizations, isolator filling line implementation, and filling line product transfers. Responsibilities include involvement in Integrated Project Planning sessions, validation impact assessments, delegating validation tasks, assisting in the writing and reviewing of regulatory submissions, and contributing to meeting project milestones. • Assist in the scheduling and implementation of the requalification program, coordinate the test activities necessary to execute the validations, and summarize the results and conclusion of the validations while following regulatory requirements. • Perform installation, operational, and performance qualification, requalification, and evaluation studies for sterilization, depyrogenation, HEPA certifications, airflow visualizations, and cleaning. • Investigate root cause analysis and implement corrective actions for deviations / exceptional conditions.

Deerfield, Illinois, Us

• Interim Floor Lead – Assisted the supervisor in organizing, scheduling and directing other team members. Main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, and validation. • Formulated medias and buffers, Cleaned-In-Place and Steamed-In-Place preparation and stationary hold vessels, operated general production equipment, assisted in troubleshooting process problems, reviewed Manufacturing Formulation Records, and assisted in the audits and assessments of the Standard Operating Procedures. • Cross-functional training in writing Exception Reports