Maria C.

• Developed regulatory strategies aligned with company's business needs, guiding global stakeholders on FDA expedited programs for combination products. • Prepared and managed drug submissions (NDA, CBEs, ARs). • Collaborated with cross-functional teams to streamline regulatory processes and enhance communication with regulatory agencies.

• Managed regulatory drug submissions (NDAs, CBEs, INDs, ODDs, FDA Meeting Packages, etc.), and assisted with Agency interactions. • Led regulatory team discussions on R&D projects and created labeling materials for Pfizer (formerly DBA Meridian Medical Technologies, a Pfizer Company).

• Reviewed manufacturing process information in CMC sections of sterile drug applications for sterility assurance. • Ensured compliance with FDA regulations and guidelines for drug product safety. • Collaborated with cross-functional teams to assess the review of NDA, ANDA and IND submissions.

• Served as the Lead Reviewer of pre-market submissions (510(k) submissions, 513(g) requests for medical device classification, IDEs, and pre-submissions) for medical devices (i.e., sterilization systems, personal protective equipment, wound dressings, catheters, infusion pumps, I.V. infusion sets, lock-flush solutions, devices coated with antimicrobials, combination products and others).

• Designed research projects to identify antimicrobial resistance mechanisms and evolutionary patterns of antibiotic resistant isolates from food animals. • Utilized molecular techniques and CLSI standardized protocols for antibiotic susceptibility testing and analyzed data to provide insights into antimicrobial resistance trends in food animals.

• Led research projects to evaluate novel protein vaccine candidates against Chlamydia infections in a mouse model. • Managed cloning and purification of recombinant proteins in an E. coli system. • Reviewed scientific data for research manuscripts and grant applications. • Organized team meetings and coordinated tasks to meet project milestones on time.