Regulatory Affairs R D

ADITI S. DESAI

206-***-**** ***********@*****.*** Tustin/Irvine (Greater LA), CA 92782 www.linkedin.com/in/aditidesairph Summary

Spearheading novel ideas through early stage and pre-clinical development processes up to Submission. Life Cycle Management and Marketed Product Innovation of Drug & Drug-Device Combination products. Looking to utilize more than 12 years’ experience in Pharmaceutical R&D and Retail Pharmacy along with my educational training in Global Regulatory Affairs and Clinical Trials Design and Research. Experienced in developing complex study designs to gather critical data for confirming feasibility of new Drug and Drug- Device combination concepts. Coordinated and oversee negotiations and subsequent research studies with Contract Research Organizations. Collaborated with many cross functional teams, including Regulatory, Pre-clinical, Manufacturing, Quality and Compliance as an Associate Program Manager to successfully advance a controlled substance drug- device combination product

(NexJect) from early-stage research to final stage submission. Core competencies:

Customer Relations Drug Development Combination Products Established Product Innovation Controlled substances Project and Risk Management Study Designing SOP Review Drug Safety Protocol Development Vendor Management Report Generation Literature Review Contract Research Organization oversight Compliance Professional Experience

PFIZER, (HOSPIRA INC.) Lake Forest, IL Dec 2014 – June 2023 Manager- Established Product Innovation (Oct 2022- June 2023) Pipeline Development-Concept Evaluation- Patient centric innovation

• Identify and develop new product opportunities associated with customer-centric innovation process and life-cycle management of Pfizer brands, utilizing sound scientific and medical information. Research established products to support development of generics.

• Perform detailed literature search in Standard of Care, Unmet needs and Pre-clinical modeling. Strategize bench to market development and commercialization cycle for each product; coordinate with regulatory team to develop submission strategy.

• Collaborate with different cross functional teams including, Medical Affairs, Device R&D, Regulatory Affairs, Program Management etc to prepare business cases for stakeholders. Prepare protocols and design studies (DOE). Senior Scientist (Jan 2018- Oct 2022)/Scientist (Dec 2014- Dec 2018) Early-Stage Development- Proof of Concept

• Advance multiple programs from bench to potentially feasible launches, including single-dose, multi-dose, ready-to-use combination injectable products for hospitals (e.g. NexJect).

• Oversee Contract Research Organizations- Source and vet CROs to make partnership decisions; negotiate costs and turnaround times. Monitor throughout project duration, ensuring adherence to protocols and regulatory guidelines.

• Ensure adherence to rules and regulations related to handling, storage, inventory, formulation preparation, testing, transfer, fill finish and disposal of controlled substances and listed drugs for Early-Stage feasibility and compatibility studies. Communicate regularly with DEA officers on site and conduct transfers and inventory documents per SOP.

• Review and interpret analytical testing reports on consumables and drug-device combination products, specifically for:

– Feasibility of creating novel formulations of sterile injectables for pain management, and

– Possibility of making device more user-friendly and safer for care provider.

• Identify potential issues early in development process to facilitate corrective action and avoid future problems.

• Mentored newly hired colleagues, facilitated their integration into the team.

• Collaborated with cross-functional stakeholders and internal clients to prioritize business needs, proactively managing feedback and resolving concerns to ensure alignment and satisfaction. ADITI S. DESAI

Page 2-206-***-**** ***********@*****.***

WALGREENS PHARMACY, Minneapolis/Saint Paul, MN

Staff Pharmacist Mar 2007 – Mar 2011

Dispense medications and Counsel patients on medications to optimize adherence to prescription regimens and prevent adverse events. Handle feedback and resolve complaints effectively.

• Monitored drug therapies for contraindications, potential for drug interaction, allergy, or incompatibility.

• Implemented methods for eliminating dosing errors; for example, created cheat sheets to prevent confusion related to sound-alike drugs or abbreviations while reducing distractions.

• Handle, dispense and account for all the controlled substances finished dosage forms in the pharmacy

• Consulted with physicians to clarify prescriptions and suggest alternate options based on patients’ drug history profile.

• Identified counterfeit or tampered prescriptions. Professional Experience in India

CHEM-IN CORPORATION, Pune, India May 2003 – Jul 2004 Manager, R&D and Manufacturing

Helped with setup and management of this startup company formed to manufacture water-testing kits developed by National Chemical Laboratory (NCL) for UNICEF.

• Oversaw approximately 10 manufacturing staff handling assembly, packaging, and quality control and assurance. Authored project plans and status reports for upper management.

• Conducted field training with users; leveraged understanding of cultural and design requirements to improve kit, enhancing accuracy and efficiency. Developed instructions for use (IFU). NATIONAL CHEMICAL LABORATORY (NCL), Pune, India

Project Assistant II, Research and Development May 2000 – May 2003 Helped develop water quality monitoring kits to detect arsenic, nitrate, and fluoride contamination in drinking water as part of project funded by UNICEF and researched and developed by NCL.

• Utilized chemical analysis, instrumental analysis (GC-MS, HPLC), and literature research to develop convenient, user-friendly testing kits.

• Trained field users to test drinking water from their own house wells. Gathered feedback from users to support improvement and modification of test kits, ensuring they were practical and affordable. Education and Credentials

UNIVERSITY OF CINCINNATI

Master of Pharmaceutical Sciences- Drug Development Curriculum includes various aspects of Drug and Device development including Target Identification, Regulatory, Preclinical & Clinical Research, Pharmacovigilance, Compliance, Program Management and Economics. PUNE UNIVERSITY, Pune, India

Bachelor of Pharmacy

Certificates & Licenses

Global Regulatory Affairs Certification (2023)- University of Cincinnati Clinical Trials Design & Research Certification (2024)- University of Cincinnati Board Certified Registered Pharmacist (R.Ph.) (FPGEE) Former licensed pharmacist in Ohio, Illinois, Wisconsin, and Minnesota.

Contact this candidate