Monica Motwani, PharmD

Key responsibilities

• Independently lead the cross-functional Labeling Working Group by driving collaboration and alignment with key stakeholders on global and local labeling strategies, and ensure compliance with health authority regulations
• Drive the development and life-cycle management of the CCDS, USPI, EU SmPC and TLP, and oversee the development of local labeling
• Present labeling strategy initiatives to executive leadership, including the CEO, in boardroom meetings to drive alignment at all levels
• Interpret, monitor, and implement regulatory guidelines in labeling
• Liaise with the labeling operations team to ensure implementation into packaging components
• Liaise with external SmPC translation vendor and conduct QC
• Mentor junior team members
• Support health authority inspections and audits

Achievements

• Two BLA labeling submissions
• Two MAA labeling submissions
• Human Factors Testing of USPI and MedGuide
• Readability testing of the EU PIL
• Authored new CCDS to support BLA and MAA indications
• Two sBLA labeling submissions
• Two Type II variation labeling submissions
• Supported development of Companion Diagnostic (CDx) label

Key responsibilities

• Led the cross-functional Labeling Working Group by driving collaboration and alignment with key stakeholders and senior management on global and local labeling strategies for the development and life-cycle management of the CCDS and USPI, and ensured compliance with health authority regulations
• Supported local affiliates with health authority requests and reviewing labeling deviations from the CCDS
• Liaised with the labeling operations team to ensure implementation into packaging components
• Supported health authority inspections and audits

Achievements

• sBLA labeling submission
• Development of Human Factors study protocol

• Facilitated CCDS updates, clinical trial data review, protocol development, market strategy, and regulatory analysis
• Developed written responses for medical drug information request

• Performed process improvements for vaccines, prepared data reports, and reviewed protocol development with regulatory guidelines.

• Supported Principal Researcher on drug safety pre-clinical testing by performing jugular IV cannulation surgeries on rats, conducting blood sampling and testing, and evaluating EKG/EEG tracings